Packaging assembly

ABSTRACT

A packaging assembly comprises a case configured to at least partially contain a plurality of injection devices for delivering a medicament; and a sensor arrangement comprising at least one device sensor; wherein the at least one device sensor is configured to detect one or more injection devices contained in the case, and to output a signal according to a result of the detection.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/487,013, filed on Aug. 19, 2019, which is the national stageentry of International Patent Application No. PCT/EP2018/054323, filedon Feb. 22, 2018, and claims priority to European Application No.17305210.1, filed on Feb. 24, 2017, the disclosures of which areincorporated herein by reference.

TECHNICAL FIELD

The application relates to a packaging assembly for a medicament and, inparticular, although not exclusively, to a packaging assembly configuredto provide a reminder alert at a scheduled dosing time.

BACKGROUND

Patients suffering chronic disease require regular treatment withmedicaments, e.g. on the basis of a predefined schedule. Particularmedicaments require refrigerated storage, and are often storedrefrigerated in a household refrigerator or fridge. In a home treatmentenvironment, the patient stores the medicament in their fridge andadministers a predefined dose as required. Hence, the medicament istypically provided in a secondary packaging for convenient placement andstorage in the household fridge. However, the medicament must be storedtogether with other items that require constant refrigeration, such asfoodstuffs and beverages.

Depending on the dosage form of the medicament, the secondary packagingcontaining the medicament may store a primary packed medicament itself,or may store one or more different kinds of drug delivery devices. Forinstance, the medicament may be provided in a pre-filled syringe orpen-type injector.

A medicament may have a predefined dosing schedule which requires theadministration of a dose at relatively long intervals, for instanceevery two or four weeks, or once a month. The medicament may be providedin a secondary packaging containing several doses which may be stored inthe fridge for 1 to 6 months for instance. It can be difficult forpatients to keep track of each scheduled dosing time.

SUMMARY

According to an embodiment, a packaging assembly is provided accordingto the claims.

These and other aspects of the disclosure will be apparent from andelucidated with reference to the embodiments described hereinafter.

BRIEF DESCRIPTION OF THE FIGURES

Embodiments of the disclosure will now be described, by way of exampleonly, with reference to the accompanying drawings, in which:

FIG. 1 is an isometric view of a packaging assembly according to a firstexemplary embodiment;

FIG. 2A is a front projection view of the packaging assembly of FIG. 1;

FIG. 2B is a front projection view of the packaging assembly of FIG. 1;

FIG. 3 is an exploded view of the packaging assembly of FIG. 1;

FIGS. 4A and 4B are side-on views of an auto-injection device for usewith the packaging assembly, according to an exemplary embodiment;

FIG. 5 is a flowchart illustrating a first exemplary operation of thepackaging assembly, according to an exemplary embodiment;

FIG. 6 is a block diagram of an electronics system of the packagingassembly, according to an exemplary embodiment;

FIG. 7 is a flowchart illustrating a second exemplary operation of thepackaging assembly, according to an exemplary embodiment;

FIG. 8 is a flowchart illustrating an exemplary user operation of thepackaging assembly according to any embodiment;

FIG. 9 is a flowchart illustrating an exemplary user operation of thepackaging assembly according to any embodiment;

FIG. 10A is a front section view illustrating a packaging assemblyaccording to an exemplary embodiment;

FIG. 10B is a front projection view illustrating a packaging assemblyaccording to an exemplary embodiment;

FIG. 10C is a front projection view illustrating a packaging assemblyaccording to an exemplary embodiment;

FIG. 11A is a front projection view illustrating a packaging assemblyaccording to an exemplary embodiment; and

FIG. 11B is a front projection view illustrating a packaging assemblyaccording to an exemplary embodiment.

DETAILED DESCRIPTION

Embodiments of the disclosure provide a packaging assembly configured tocontain and store a plurality of injection devices for delivering amedicament. An injection device is an example of a drug delivery deviceand may be a pen-injector or an auto-injector. The packaging assembly isconfigured to detect the injection devices stored therein, and may beconfigured to contain a plurality of types of injection device. Thepackaging assembly is configured to provide an audio and/or visualreminder to a patient at a scheduled dosing time for each injectiondevice. The packaging assembly may further include one or more userinterface elements for providing the patient with a status andinformation relating to a status of the packaging assembly. Thepackaging assembly provides a predictable, easy to use operation for thepatient.

The packaging assembly may be stored in a household refrigerator orfridge. The packaging assembly may include a door open sensor todetermine whether or not the fridge is open. The packaging assembly maybe configured to provide the reminder or a user interface outputconditional on the fridge door being open. The packaging assemblyprovides information easily and intuitively, and allows safe storage ina fridge for convenient and discreet use by the patient.

The packaging assembly may determine whether or not the packagingassembly has been opened. The packaging assembly may deactivate thereminder upon detection of the packaging assembly being opened. Theoperation of the packaging assembly is predictable and intuitive for thepatient.

A drug delivery device, as described herein, may be configured to injecta medicament into a patient. For example, delivery could besub-cutaneous, intra-muscular, or intravenous. Such an injection devicecould be operated by a patient or care-giver, such as a nurse orphysician, and can include various types of safety syringe,pen-injector, or auto-injector. The injection device can include acartridge-based system that requires piercing a sealed ampule beforeuse. Volumes of medicament delivered with these various injectiondevices can range from about 0.2 ml to about 3 ml. Yet another injectiondevice can be represented by a large volume device (“LVD”) or patchpump, configured to adhere to a patient's skin for a period of time(e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volumeof medicament (typically about 2 ml to about 10 ml).

In combination with a specific medicament, the presently describedinjection devices may also be customized to operate within requiredspecifications. For example, the device may be customized to inject amedicament within a certain time period (e.g., about 3 to about 20seconds for auto-injectors, and about 10 minutes to about 60 minutes foran LVD). Other specifications can include a low or minimal level ofdiscomfort, or to certain conditions related to human factors,shelf-life, expiry, biocompatibility, environmental considerations, etc.Such variations can arise due to various factors, such as, for example,a drug ranging in viscosity from about 3 cP to about 50 cP.Consequently, an injection device will often include a hollow needleranging from about 25 to about 31 Gauge in size. Common sizes are 27 and29 Gauge.

The injection devices described herein can also include one or moreautomated functions. For example, one or more of needle insertion,medicament injection, and needle retraction can be automated. Energy forone or more automation steps can be provided by one or more energysources. Energy sources can include, for example, mechanical, pneumatic,chemical, or electrical energy. For example, mechanical energy sourcescan include springs, levers, elastomers, or other mechanical mechanismsto store or release energy. One or more energy sources can be combinedinto a single device. Devices can further include gears, valves, orother mechanisms to convert energy into movement of one or morecomponents of a device.

The one or more automated functions of an auto-injector may be activatedvia an activation mechanism. Such an activation mechanism can includeone or more of a button, a lever, a needle sleeve, or other activationcomponent. Activation may be a one-step or multi-step process. That is,a user may need to activate one or more activation mechanisms to causethe automated function. For example, a user may depress a needle sleeveagainst their body to cause injection of a medicament. In other devices,a user may be required to depress a button and retract a needle shieldto cause injection.

In addition, such activation may activate one or more mechanisms. Forexample, an activation sequence may activate at least two of needleinsertion, medicament injection, and needle retraction. Some devices mayalso require a specific sequence of steps to cause the one or moreautomated functions to occur. Other devices may operate with sequenceindependent steps.

Some delivery devices can include one or more functions of a safetysyringe, pen-injector, or auto-injector. For example, a delivery devicecould include a mechanical energy source configured to automaticallyinject a medicament (as typically found in an auto-injector) and a dosesetting mechanism (as typically found in a pen-injector).

With reference to FIG. 1, a packaging assembly 100 according toexemplary embodiments is shown. The packaging assembly 100 comprises acase 110 having a lid 120. The case 110 comprises a lower face 131, anupper face 141, and two side walls 142. The lower face 131 is curved soas to meet the upper face 141 at the rear of the device. Ata front endof the case 110, an opening is formed between lower face 131, the upperface 141 and the two side walls 142.

The lid 120 of the case 110 is arranged to cover the opening of the case110. The lid 120 is attached between the two side walls 142 of the case110 in a hinged manner. The lid 120 can be freely moved in a hingedmanner between a closed position and an open position. In the closedposition, the lid 120 is arranged to cover the opening of the case 110.In the open position, the opening of the case 110 is uncovered and aninterior of the case 110 can be accessed.

The lid 120 may comprise a latching mechanism to hold the lid 120 in theclosed position. The latching mechanism may comprise a protruding partarranged at an edge of the lid 120. The protruding part may beconfigured to engage with a corresponding feature in the case 110 whenthe lid is in the closed position. The protruding part may be flexibleor retractable to disengage from the case 110 and allow the lid 120 tomove to the open position.

The case 110 is configured to hold and store a plurality of injectiondevices 10. A length of the case 110, measured between the rear of thecase and the lid 120, is sufficient to accommodate the length of each ofthe injection devices 10. The length of the case may be between 160 mmand 180 mm. A depth of the case 110, measured between the top face 141and the lower face 131, is sufficient to accommodate the width of eachof the injection devices 10. The depth of the case may be between 30 mmand 40 mm. A width of the case 110, measured between the two side walls142, is sufficient to accommodate six injection devices 10. The width ofthe case may be between 180 mm and 200 mm. In some examples, the casemay be 188.7 mm wide, 174.7 mm high and 34 mm deep.

As shown in FIG. 1, the lower face 131 of the case 110 is shorter thanthe upper face 141. The lid 120 extends from a front edge of the lowerface 131 to a front edge of the upper face 141. The lid 120 is curved.The curve allows the lid 120 to form the front and a portion of thebottom of the case 110 in the closed position. Other lid configurationsare also contemplated.

The lower face 131, the upper face 141 and the two side walls 142 areformed from an opaque material, for example, an opaque plastic material.The lid 120 is formed from a translucent or frosted material, forexample, a clear plastic material with a frosted coating or a treatedsurface. A portion of the lid 120 is clear and transparent to form aviewing window 121 through the lid 120.

The case 110 further comprises a panel 150 arranged within the opening.The panel 150 is visible only when the lid 120 of the case 110 is in anopen position; when the lid 120 is in the closed position, the lidobscures the panel 150 from view. The panel 150 comprises a plurality ofopenings 151. The openings 151 are configured to hold a correspondingplurality of injection devices 10. The openings 151 in the panel 150 arecircular in shape. The openings 151 may be square shaped, or rectangularshaped to accommodate other sizes of injection device 10. The width ofeach opening is sufficient to accommodate the width of each injectiondevice 10. The panel 150 comprises a row of six openings, so as to holdsix injection devices 10 arranged in a row along a width of the case110.

The packaging assembly 100 may be configured to hold more than six, orfewer than six injection devices 10 in the case 110.

The lid 120 may be configured to retain the plurality of injectiondevices 10 in position within the case 110 when in the closed position.The lid 120 may be arranged in the closed position to prevent theinjection devices 10 from falling or sliding out of the case 110. Eachinjection device 10 may be retained in position within the correspondingopening 151 by a friction fit with the opening 151.

A retention mechanism may retain the plurality of injection devices 10in position within the openings 151. The retention mechanism maycomprise a mechanical catch configured to engage with each injectiondevice 10, for example, a sprung push-catch push-release mechanism. Theinjection device 10 is pushed into the opening 151 and pushed against aspring of the retention mechanism to engage a catch, the injectiondevice 10 is pushed a second time to release the catch. A release buttonor switch may be provided for each of the openings 151, which isconfigured to release the catch of the retention mechanism when pressed.

A user may receive the packaging assembly 100 in an empty condition.When the user is supplied with a plurality of injection devices 10 theycan be loaded into the packaging assembly 100. The lid 120 is moved intothe open position and each of the injection devices 10 is inserted intoa corresponding one of the openings 151. The lid 120 is moved into theclosed position. The packaging assembly 100 is placed in the fridgeuntil the first scheduled dosing time is due. The packaging assembly 100may be placed in the fridge before or after the initial insertion ofinjection devices 10.

For example, a dosing time for one type of injection device 10 may bescheduled every 14 days or 28 days, according to the prescription and/orproduct patient leaflet of the medicament provided with the injectiondevice 10. For some injection devices 10, a period of time betweenscheduled dosing times may be between 2 days and 60 days, according tothe requirements of the medicament. The packaging assembly 100 may beconfigured to contain and store injection devices 10 of multiple types,simultaneously or at different points in time. The packaging assembly100 may contain a plurality of injection devices 10 providing one ormore different medicaments with one or more different dosing intervals.

The packaging assembly 100 is configured to provide the user with avisual and/or audio reminder when a scheduled dosing time is due. Thepackaging assembly 100 is further configured to determine whether or notthe fridge door is open, and to provide the reminder conditional on thefridge door being open. The packaging assembly 100 is further configuredto determine whether the lid 120 is in the open position or the closedposition, and to deactivate the audio reminder upon detection of the lid120 being moved to the open position.

FIG. 2A shows the packaging assembly 100 from the front with the lid 120in the open position. The panel 150 and openings 151 are visible. Thepackaging assembly 100 as shown contains a plurality of injectiondevices 10, each of which may be of a different device type. Differenttypes of injection device 10 may provide different medicaments.Alternatively, different types of injection device 10 may have differentdosages or concentrations of the same medicament, or different methodsof delivering the medicament. Different types of injection device 10 mayhave different dosing intervals.

The packaging assembly 100 includes an electronics system 200. Theelectronics system 200 comprises multiple components that are connectedtogether to provide a specific set of functions, described below. Thecomponents of the electronics system 200 are mounted on a printedcircuit board (PCB 201), although instead they may be interconnectedthrough some other medium.

The electronics system 200 is attached to the panel 150. Some of theelectronic components of the electronics system 200 are user interfacehardware components and together provide a user interface 210 for thepackaging assembly 100.

The electronics system 200 comprises a display 211. The display 211 isan example of an optical transducer. The display 211 comprises twoseven-segment light-emitting diode (LED) arrays. The display 211 isvisible to the user through the transparent viewing window 121 in thelid 120. The electronics system 200 comprises a light-emitting diode(LED) array 220. The LED array 220 is an example of an opticaltransducer. The electronics system 200 comprises a reset button 164. Thereset button 164 is an example of an input device. The reset button 164is a sprung plunger button which may be depressed by the user. Theelectronics system 200 comprises a speaker 213 (not shown in thisFigure). The speaker 213 is an example of an audio transducer.

The LED array 220 comprises an array of eighteen light-emitting diodes(LEDs). The LEDs of the LED array 220 are arranged on the panel 150, inproximity to the openings 151. The LED array 220 comprises three LEDs221,222,223 for each of the six openings 151. Each of the three LEDs221,222,223 can be illuminated with a different colour. For example, theLED array 220 may comprise a blue LED 221, a white LED 222 and a red LED223 for each opening 151.

FIG. 2B shows an internal view of the packaging assembly 100 from thefront. The rear face of the PCB 201 is illustrated.

The electronics system 200 comprises a sensor array 240. The sensorarray 240 is mounted on a rear face of the PCB 201. The sensor array 240comprises a plurality of device sensors 241. The number of devicesensors 241 corresponds to the number of injection devices 10 which canbe stored by the packaging assembly 100. Each device sensor 241 ismounted in proximity to one of the plurality of openings 151.

The device sensor 241 is configured to output a signal when an injectiondevice 10 is located in the opening 151 or during insertion into opening151. The device sensor 241 is a radio-frequency identification (RFID)reader comprising a radio-frequency antenna. Each device sensor 241 isin the form of a loop corresponding to each of the openings 151. Thedevice sensor 241 is arranged to detect a device tag 30 arranged on theinjection device 10. The device tag 30 is a passive RFID tag comprisinga radio-frequency antenna. The device sensor 241 generates anelectromagnetic field, which activates the device tag 30, and detects aresponse signal transmitted by the device tag 30. The device sensor 241may be configured to read device information stored on the device tag30. The processor arrangement 230 may store device information receivedfrom an injection device 10.

The sensor array 240 may include electronic components that are separateto the device sensors 241 but form part of the sensor array 240 itself.The device sensors 241 may provide signals transmitted by a device tag30 and the electronic components perform analysis of the signal andcommunication to the processor arrangement 230. Alternatively, eachdevice sensor 241 may include electronic components to perform analysisof a detected signal. Further alternatively, the analysis of incomingsignals may be performed by the processor arrangement 230.

The electronics system 200 is shown schematically in FIG. 6. Theelectronics system 200 comprises a processor arrangement 230. Theprocessor arrangement 230 controls operation of the other hardwarecomponents of the electronics system 200. The processor arrangement 230is configured to control the hardware components which form the userinterface 210. The processor arrangement 230 is configured to processone or more input signals from at least one input sensor.

With reference to FIG. 3, an exploded view of the packaging assembly 100according to the first embodiment is shown. The case 110 of thepackaging assembly 100 comprises a first part 130 and a second part 140.The first part 130 of the case 110 is formed from a single piece. Thefirst part 130 of the case 110 comprises the lower face 131 and the rearof the packaging assembly 100. Along each side edge of the lower face131, a plurality of openings 133 are formed for engaging with the secondpart 140 of the case 110. Three openings 133 are formed along each edgeof the first part 130. The first part 130 further comprises a pluralityof dividers 134 for holding the plurality of injection devices 10 (notshown in FIG. 3) in position within the case 110.

The second part 140 comprises the upper face 141, a first side wall 142a and a second side wall 142 b of the case 110. The second part 140 isformed from a single piece. The second part 140 further comprises aplurality of dividers 144 for holding and storing the plurality ofinjection devices 10 in position within the case 110. The dividers 144of the second part 140 are aligned with the dividers 134 of the firstpart 130.

The case 110 of the packaging assembly 100 comprises a plurality ofmagnets 148. The magnets 148 are fixed in position on an internal sideof the upper face 141. The case comprises four magnets 148 fixed in asquare arrangement. The plurality of magnets 148 allows the upper face141 of the case 110 to be releasably attached to a magnetic surface, forexample, a steel surface. The magnets 148 may be neodymium magnets.

The packaging assembly 100 further comprises a mounting plate 190. Themounting plate 190 comprises a plurality of adhesive strips 191. Themounting plate 190 can be fixed to a surface using the adhesive strips191, such as, for example, a wall or under a shelf within a fridge. Themounting plate 190 is formed from a magnetic material, for example,steel. The case 110 can be releasable attached to the surface bymagnetically attaching to the beforehand fixed mounting plate 190.

The mounting plate 190 comprises three adhesive strips 191. The adhesivestrips 191 are arranged in parallel across the width of the mountingplate 190 and each adhesive strip 191 extends along substantially thefull length of the mounting plate. Alternatively, the mounting plate 190may comprise only two adhesive strips 191 which are spaced apart on themounting plate 190, or may comprise more than three adhesive strips 191extending in parallel. Further alternatively, the mounting plate 190 maycomprise four adhesive strips 191 positioned in a rectangulararrangement, for example, at each corner of the mounting plate 190. Themounting plate may comprise any number of adhesive strips 191 arrangedin a regular array.

The mounting plate 190 may alternatively be placed, without adhesive, onan upper side of a shelf. The case 110 may be magnetically held beneaththe shelf through a magnetic attraction to the mounting plate 190.

The packaging assembly 100 further comprises a plurality of batteries170. The batteries 170 are arranged to provide power to the componentsof the electronic system 200, including the user interface 210. Thesecond part 140 of the case 110 comprises a battery opening 145 formedin the upper face 141. The battery opening 145 is configured to receivethe plurality of batteries 170. A battery cover 180 is configured toslidably engage with the battery opening 145 of the second part 140 andto cover the battery opening 145 when the packaging assembly 100 is inuse. The battery cover 180 comprises a plurality of latches 181 arrangedto engage with the second part 140 of the case 110.

Each of the first side wall 142 a and the second side wall 142 b of thecase 110 comprises a plurality of engaging hooks 143. The engaging hooks143 are arranged on an inner face of the respective side wall. Each ofthe side walls 142 comprises three engaging hooks 143. The engaginghooks 143 are each configured to engage with the corresponding opening133 in the first part 130 of the case 110. Each of the side walls 142comprises a first hinging part 146. Each of the side walls 142 comprisesa first latching part 147.

The lid 120 of the case 110 comprises a second hinging part 126configured to engage with the first hinging part 146 of the second part140 of the case 110. The first hinging part 146 and the second hingingpart 126 together form a hinge 106 for attaching the lid 120 to thesecond part 140 of the case 110. For example, the first hinging part 146comprises an opening and the second hinging part 126 comprises aprotrusion arranged to fit within the opening of the first hinging part146. The second hinging part 126 is configured to rotate within theopening of the first hinging part 146.

The lid 120 of the case 110 comprises a second latching part 127configured to engage with the first latching part 147 of the second part140 of the case 110. The second latching part 127 is configured toreleasably engage with the first latching part 147 to maintain the lid120 in a closed position. For example, the first latching part 147comprises an opening and the second latching part 127 comprises aprotrusion configured to releasably engage with the opening of the firstlatching part 147.

The lid 120 is formed from a translucent plastic material. A portion ofthe lid 120 is clear and transparent to form a viewing window 121through the lid 120.

The panel 150 is held in position between the first part 130 and thesecond part 140 of the case 110. The panel 150 comprises the pluralityof openings 151. The openings 151 are configured to hold thecorresponding plurality of injection devices 10. The panel 150 furthercomprises one or more openings 152 for the hardware components of theuser interface 210. The packaging assembly 100 comprises the electronicssystem 200. The electronics system 200 includes the hardware componentsof the user interface 210, namely the display 211, the LED array 220,the speaker 213 and the reset button 164. The display 211 of the userinterface 210 is visible through the transparent viewing window 121 ofthe lid 120.

A plurality of screws 168 are arranged to attach a support of theelectronics system 200, for instance a PCB 201, to a rear face of thepanel 150. The sensor array 240 is mounted on the rear face of the PCB201. Alternatively, the sensor array 240 may be arranged on the frontface of the PCB 201. Further alternatively, the sensor array 240 may bearranged on the rear face of the panel 150. The electronics system 200is coupled with a battery contact 169. The battery contact 169 ismounted with the plurality of batteries 170 to supply power to theelectronics system 200.

The electronics system 200 comprises a reset switch 215. The resetbutton 164 is a sprung plunger button arranged to be pushed by the user.The reset switch 215 is a mechanical switch mounted on the electronicssystem 200. The reset switch 215 is positioned below the reset button164. The reset switch 215 is arranged to be actuated by the reset button164. The reset button 164 may be coupled to the reset switch 215.

The electronics system 200 comprises a light sensor 251. The lightsensor 251 is mounted on the PCB 201 of the electronics system 200. Thelight sensor 251 comprises a phototransistor configured to pass acurrent according to the amount or intensity of light which is incidenton the light sensor 251. The light sensor 251 is an example of a fridgeopen sensor.

The light sensor 251 may be of the type where the inherent devicecharacteristics are such that an intensity of light exceeding athreshold results in a signal of one type (e.g. high) and an intensityof light below the threshold results in a signal of an opposite type(e.g. low). Alternatively, comparison of the intensity to a thresholdmay be performed by electronic components that are separate to thedevice of the light sensor 251 but form part of the light sensor itself.Here, the light sensitive device provides a signal with a level thatvaries according to the detected light intensity and the electroniccomponents perform analysis of the signal compared to a threshold.

Further alternatively, the comparison may be performed in the digitaldomain by the processor arrangement 230. Here, the light sensor providesa signal with a level that varies according to the detected lightintensity, this is converted by an analogue to digital converter (if notalready a digital signal) and the processor arrangement compares thesignal to a threshold. Unless the threshold is inherent in the device,the threshold may be preset (that is, predetermined and set at thedesign or manufacture stage) or it may be dynamically adjustable havingregard to operating conditions.

The arrangement may be configured to filter out short duration bursts oflight exceeding the threshold, which filtering may occur through the useof slow response components, so as to reduce the occurrence of falsetriggering. As will be appreciated, if there is false triggering fromshort duration periods of light intensity exceeding the threshold, theresult is short duration activation of user interface components.

The electronics system 200 comprises a hinge switch 252. The hingeswitch 252 may be an electro-mechanical switch such as a microswitch orother miniature snap action switch. The hinge switch 252 is an exampleof a lid open sensor.

The hinge switch 252 is arranged to engage with the lid 120 of the case110 when the lid 120 is in a closed position. An actuating part 128 ofthe lid 120 is shaped so as to press the hinge switch 252 when the lid120 is in a closed position. The hinge switch 252 is mounted at an edgeof the PCB 201 of the electronics system 200. The actuating part 128 ofthe lid 120 is arranged to pass the edge of the PCB 201 of theelectronics system 200 when the lid 120 is in a closed position.

The electronics system 200 further comprises the processor arrangement230 (not shown in this Figure). The processor arrangement 230 isconfigured to process the input signals from the one or more sensors andthe switches on the electronics system 200. The processor arrangement230 is configured to control the outputs of the user interface elementson the electronics system 200.

With respect to FIGS. 4A and 4B, an exemplary injection device 10 isshown. Injection device 10, as described above, is configured to injecta medicament into a user's body. Injection device 10 includes a housing11 which typically contains a reservoir containing the medicament to beinjected (e.g., a syringe) and the components required to facilitate oneor more steps of the delivery process. Injection device 10 can alsoinclude a cap assembly 12 that can be detachably mounted to the housing11. Typically a user must remove cap 12 from housing 11 before injectiondevice 10 can be operated.

As shown, housing 11 is substantially cylindrical and has asubstantially constant diameter along the longitudinal axis X. Thehousing 11 has a proximal region 20 and a distal region 21. The term“proximal” refers to a location that is relatively closer to a site ofinjection, and the term “distal” refers to a location that is relativelyfurther away from the injection site.

Injection device 10 can also include a needle sleeve 13 coupled tohousing 11 to permit movement of sleeve 13 relative to housing 11. Forexample, sleeve 13 can move in a longitudinal direction parallel tolongitudinal axis X. Specifically, movement of sleeve 13 in a distaldirection can permit a needle 17 to extend from proximal region 20 ofhousing 11.

Insertion of needle 17 can occur via several mechanisms. For example,needle 17 may be fixedly located relative to housing 11 and initially belocated within an extended needle sleeve 13. distal movement of sleeve13 by placing a proximal end of sleeve 13 against a user's body andmoving housing 11 in a proximal direction will uncover the proximal endof needle 17. Such relative movement allows the proximal end of needle17 to extend into the user's body. Such insertion is termed “manual”insertion as needle 17 is manually inserted via the user's manualmovement of housing 11 relative to sleeve 13.

Another form of insertion is “automated,” whereby needle 17 movesrelative to housing 11. Such insertion can be triggered by movement ofsleeve 13 or by another form of activation, such as, for example, abutton 22. As shown in FIGS. 4A and 4B, button 22 is located at a distalend of housing 11. However, in other embodiments, button 22 could belocated on a side of housing 11.

Other manual or automated features can include drug injection or needleretraction, or both. Injection is the process by which a bung or piston23 is moved from a distal location within a syringe (not shown) to amore proximal location within the syringe to force a medicament from thesyringe through needle 17. In some embodiments, a drive spring (notshown) is under compression before device 10 is activated. A distal endof the drive spring can be fixed within distal region 21 of housing 11,and a proximal end of the drive spring can be configured to apply acompressive force to a distal surface of piston 23. Followingactivation, at least part of the energy stored in the drive spring canbe applied to the distal surface of piston 23. This compressive forcecan act on piston 23 to move it in a proximal direction. Such proximalmovement acts to compress the liquid medicament within the syringe,forcing it out of needle 17.

Following injection, needle 17 can be retracted within sleeve 13 orhousing 11. Retraction can occur when sleeve 13 moves proximally as auser removes device 10 from a user's body. This can occur as needle 17remains fixedly located relative to housing 11. Once a proximal end ofsleeve 13 has moved past a proximal end of needle 17, and needle 17 iscovered, sleeve 13 can be locked. Such locking can include locking anydistal movement of sleeve 13 relative to housing 11.

Another form of needle retraction can occur if needle 17 is movedrelative to housing 11. Such movement can occur if the syringe withinhousing 11 is moved in a distal direction relative to housing 11. Thisdistal movement can be achieved by using a retraction spring (notshown), located in proximal region 20. A compressed retraction spring,when activated, can supply sufficient force to the syringe to move it ina distal direction. Following sufficient retraction, any relativemovement between needle 17 and housing 11 can be locked with a lockingmechanism. In addition, button 22 or other components of device 10 canbe locked as required.

Injection device 10 comprises a device tag 30, for example, a passiveRFID tag. The device tag 30 may internally or externally mounted on thehousing 11. The device tag 30 is configured to activate when placed inan electromagnetic field, and to output a response signal whenactivated.

The device tag 30 is arranged at a midpoint of the housing 11, betweenproximal region 20 and distal region 21. The device tag 30 is arrangedto align with the device sensor 241 when the injection device 10 ismoved through the opening 151 of the packaging assembly 100. In thisway, the device tags 30 of injection devices 10 stored in the packagingassembly 100 are separated from the sensor array 240, improving theclarity of detection. Furthermore, the speed of the injection device 10is generally greatest as the midpoint of the injection device 10 ismoving through the opening 151. The device tag 30 is therefore activatedfor a shorter period of time, and the power consumption of the devicesensor 241 can be minimised.

The response signal of the device tag 30 may include information relatedto the injection device 10. Information may be stored on the device tag30 and transmitted as part of the response signal when the device tag 30is activated. The device tag 30 may store one or more of a device ID,device type, expiry date, dosing time period and warm-up time period ofthe injection device 10.

The packaging assembly 100 may contain or store a plurality of differenttypes of injection device 10 with different information stored on eachdevice tag 30. Each injection device 10 may have a different expirydate, dosing time period and/or warm-up time period stored in the devicetag 30.

A first exemplary operation of the packaging assembly 100 will now bedescribed with reference to the flow chart of FIG. 5. In the following,actions said to be made by the packaging assembly 100 typically are madeby the electronics system 200 and, in particular, by the processorarrangement 230 operating according to instructions to control thecomponents of the electronics system 200. The flow chart of FIG. 5 isschematic.

The Operation Starts at Step 5.1.

At step 5.2, the processor arrangement 230 determines whether a fridgedoor of a fridge in which the packaging assembly 100 is stored is openor closed. If the fridge door is partially open, then the processorarrangement 230 determines the fridge door to be open. That is, thefridge door is determined to be open if it is not closed. If the fridgedoor is determined to be open, the operation proceeds to step 5.3.Otherwise, it stays at step 5.2 until the fridge door is determined tobe open. The user interface 210 can be controlled by the processorarrangement 230 according to whether the fridge door is detected to beopen or closed.

At step 5.3, the processor arrangement 230 determines whether the lid120 of the packaging assembly 100 is in the open position or the closedposition. The user interface 210 can be controlled by the processorarrangement 230 according to whether or not the lid 120 is open. If thelid 120 is open, the processor arrangement 230 proceeds to step 5.4.Otherwise, the processor arrangement 230 proceeds to step 5.10.

At step 5.4, the processor arrangement 230 determines whether aninjection device 10 is detected by the sensor array 240. The sensorarray 240 may detect an injection device 10 as the injection device 10is moved into or out of an opening 151. If an injection device 10 isdetected by the sensor array 240, the processor arrangement 230 proceedsto step 5.5. Otherwise, the processor arrangement 230 proceeds to step5.7.

At step 5.5, the processor arrangement 230 receives device informationfrom the detected injection device 10, and updates device informationwhich is stored by the processor arrangement 230. The processorarrangement 230 can increase or decrease a count of the number ofinjection devices 10 stored in the packaging assembly 100, according tothe insertion or removal of an injection device 10. Where a newinjection device 10 is detected as it is inserted into an opening 151,the processor arrangement 230 can increase the count of the number ofinjection devices 10. Where a stored injection device 10 is detected asit is removed from an opening 151, the processor arrangement 230 candecrease the count of the number of injection devices 10. The processorarrangement updates a device index for injection devices 10 of the sametype. The device index indicates the number of injection devices 10 ofthe same type.

The user interface 210 can be controlled by the processor arrangement230 according to whether an injection device 10 is stored in thepackaging assembly 100, and according to device information receivedfrom the injection device 10. At step 5.6, the processor arrangement 230updates one or more active countdown timers based on the deviceinformation received from the one or more injection devices 10 andstored information about injection devices 10 stored in the packagingassembly 100. The processor arrangement 230 then proceeds to step 5.7.

At step 5.7, the processor arrangement 230 checks whether or not thereset button 164 is pressed, that is to say whether it is currentlybeing operated by a user. If the reset button 164 is pressed, theprocessor arrangement 230 proceeds to step 5.8. At step 5.8, theprocessor arrangement 230 resets the completed countdown timer. Theprocessor arrangement 230 resets the active countdown timers which havereached zero.

If the reset button 164 is not determined to be pressed at step 5.7, theprocessor arrangement 230 proceeds to step 5.9. At step 5.9, theprocessor arrangement 230 checks the expiry date of one or moreinjection devices 10 stored in the packaging assembly 100. The userinterface 210 can be controlled according to the expiry date of the oneor more injection devices 10.

At step 5.10, the processor arrangement 230 checks the state of chargeof one or more batteries 170 included in the packaging assembly 100. Theuser interface 210 can be controlled by the processor arrangement 230according to the state of change of the battery 170.

At step 5.11, the processor arrangement checks the lowest activecountdown timer. The processor arrangement 230 can determine the timeremaining (e.g. the number of days remaining) until the next scheduleddosing time. The user interface 210 can be controlled by the processorarrangement 230 according to whether or not the reset button 164 ispressed, and/or according to the state of the lowest active countdowntimer of the processor arrangement 230.

At step 5.12, the processor arrangement 230 checks the device index ofone or more injection devices 10 stored in the packaging assembly 100.The user interface 210 can be controlled according to the device indexof the one or more injection devices 10. The processor arrangement 230can remove an active countdown timer for a device type of injectiondevice 10 based on the device index of the respective device type.

At step 5.13, the processor arrangement 230 checks a door open timer.The processor arrangement 230 monitors the amount of time that the doorof the fridge has been open using the door open timer. The userinterface 210 can be controlled by the processor arrangement 230according to the door open timer of the processor arrangement 230.

At step 5.14, the processor arrangement 230 controls the hardwarecomponents of the electronics system 200 which form the user interface210. The user interface 210 is controlled based on the determinationsmade at any of steps 5.2, 5.3, 5.4, 5.7, 5.9, 5.10, 5.11, 5.12 and 5.13.

The packaging assembly 100 is configured to output a reminder alert ifthe next scheduled dosing time is due. The packaging assembly 100 isconfigured to output the reminder alert conditional on the door of thefridge being open. The packaging assembly 100 is configured todeactivate the audio reminder alert upon detection of the lid 120 beingmoved from the closed position to the open position. The packagingassembly 100 is configured to enter a partial sleep state when theamount of time measured by the door timer is over a defined thresholdtime.

The packaging assembly 100 is configured to output an indication if theexpiry date of one or more injection devices 10 stored in the packagingassembly 100 is passed. The packaging assembly 100 is configured tooutput an indication if the state of charge of one or more batteries 170included in the packaging assembly 100 is low.

The Operation Finishes at Step 5.15.

With respect to FIG. 6, a schematic representation of the electronicssystem 200 of the packaging assembly 100 according to the firstembodiment is shown. The electronics system 200 comprises the processorarrangement 230. The processor arrangement 230 and other hardwarecomponents may be connected via a system bus (not shown). Each hardwarecomponent may be connected to the system bus either directly or via aninterface. One or more batteries 170 are arranged to provide power tothe electronics system 200.

The processor arrangement 230 controls operation of the other hardwarecomponents of the electronics system 200. The processor arrangement 230may be an integrated circuit of any kind. The processor arrangement 230may for instance be a general purpose processor. It may be a single coredevice or a multiple core device. The processor arrangement 230 may be acentral processing unit (CPU) or a general processing unit (GPU).Alternatively, it may be a more specialist unit, for instance a RISCprocessor or programmable hardware with embedded firmware. Multipleprocessors may be included. The processor arrangement 230 may be termedprocessing means.

The processor arrangement 230 has an internal processing clock speed ofabout 4 MHz. The processor arrangement 230 also has a stand-by clockspeed of 2Hz to reduce energy consumption. The internal processing clockspeed and stand-by clock speed are selected to provide a balance betweenpower usage and usability. A greater clock speed provides improvedusability by reducing the time required for the processor arrangement230 to respond to an input. However, a greater clock speed will increasethe power usage of the processor arrangement 230. The stand by clockspeed may be selected between 0.5 and 100 Hz.

The electronics system 200 comprises a working or volatile memory 232.The processor arrangement 230 may access the volatile memory 232 toprocess data and may control the storage of data in memory. The volatilememory 232 may be a RAM of any type, for example Static RAM (SRAM),Dynamic RAM (DRAM), or it may be Flash memory. Multiple volatilememories may be included, but are omitted from the Figure.

The electronics system 200 comprises a non-volatile memory 233. Thenon-volatile memory 233 stores a set of operation instructions forcontrolling the normal operation of the processor arrangement 230. Thenon-volatile memory 233 may be a memory of any kind such as a Read OnlyMemory (ROM), a Flash memory or a magnetic drive memory. Othernon-volatile memories may be included, but are omitted from the Figure.

The processor arrangement 230 operates under the control of theoperating instructions. The operating instructions may comprise code(i.e. drivers) relating to the hardware components of the electronicssystem 200, as well as code relating to the basic operation of thepackaging assembly 100. The operating instructions may also causeactivation of one or more software modules stored in the non-volatilememory 233. Generally speaking, the processor arrangement 230 executesone or more instructions of the operating instructions, which are storedpermanently or semi-permanently in the non-volatile memory 233, usingthe volatile memory 232 temporarily to store data generated duringexecution of the operating instructions.

The processor arrangement 230, the volatile memory 232 and thenon-volatile memory 233 may be provided as separate integrated circuitchips connected by an off-chip bus, or they may be provided on a singleintegrated circuit chip. The processor arrangement 230, the volatilememory 232 and the non-volatile memory 233 may be provided as amicrocontroller.

The electronics system 200 comprises a clock 234. The clock 234 may be aclock crystal, for example, a quartz crystal oscillator. The clock 234may be a separate component to the processor arrangement 230 which isconfigured to provide a clock signal to the processor arrangement 230.The processor arrangement 230 may be configured to provide a real timeclock based on the signal from the clock 234. Alternatively, the clock234 may be a clock crystal which is provide on a single integratedcircuit chip with the processor arrangement 230.

The processor arrangement 230 is configured to perform at least onecountdown operation. The processor arrangement 230 may perform adifferent countdown operation for each different type of injectiondevice 10 stored in the packaging assembly 100. The processorarrangement 230 monitors the one or more countdown operations todetermine the number of days remaining until the next scheduled dosingtime. Countdown operations are set and activated in response to theinsertion of an injection device 10 into one of the openings 151,detected by the sensor array 240. The processor arrangement 230 recordsthe number of days for each countdown timer to the volatile memory 232and every 24 hours reduces the recorded number of days by one.

The predetermined time period for each countdown to the next scheduleddosing time may be different for each different type of device. Forexample, if a time period until the next scheduled dosing time is due is14 days for a certain type of device, the countdown timer for that typeof device is started from 14 days. If a time period until the nextscheduled dosing time is due is 28 days for another type of device, thecountdown timer for that type of device is started from 28 days.

Every 24 hours, the number of days recorded to the volatile memory 232is reduced by one. The processor arrangement 230 monitors the lowestactive countdown to determine the number of days remaining until thenext scheduled dosing time. When 1 day remains until the next scheduleddosing time, the processor arrangement 230 may control the electronicssystem 200 to generate an output to indicate that the next scheduleddosing time is near. On the day of the scheduled dosing time, theprocessor arrangement 230 may control the electronics system 200 togenerate an output to indicate that the next scheduled dosing time isdue. The hardware components of the electronics system 200 which formthe user interface 210 may be controlled to indicate that the nextscheduled dosing time is due. The user interface 210 may by controlledto indicate that the next scheduled dosing time is due for a certaindevice type, or for the injection device 10 stored in a certain opening151.

On one day, for instance the first or last day, the reduction of thenumber of days may be provided in less than 24 hours. For instance, itmay be achieved in 20 hours or 22 hours. This can help to prevent creepof the alert time to later and later in the day after multiple resets ofthe countdown timer. Alternatively, when the remaining number of daysrecorded in the volatile memory is equal to one, the processorarrangement 230 may be configured to reduce the time remaining until thenext scheduled dosing time is due. For example, the processorarrangement 230 may be configured to wait only 23 hours before reducingthe number of days to zero. In this way, the time of day at which thescheduled dosing time becomes due is one hour earlier than the time atwhich the reset button 164 was pressed.

The processor arrangement 230 may be configured to perform one or moretiming operations. For example, the processor arrangement 230 mayoperate a door timer to monitor the amount of time that the door of thefridge has been open. The processor arrangement 230 may operate a resettimer to monitor the amount of time that the reset button 164 has beenpressed. The processor arrangement 230 may start a timing operation fromzero and monitor an increasing amount of time. Alternatively, theprocessor arrangement 230 may start a timing operation from apredetermined time and count down until the timer expires.

The processor arrangement 230 may be configured to provide a currentdate and time based on the signal from the clock 234. The processorarrangement 230 may monitor the expiry date for each injection device 10stored in the packaging assembly 100. The processor arrangement 230 maydetermine that an injection device 10 has expired when the expiry dateis in the past. The the processor arrangement 230 may control theelectronics system 200 to generate an output to indicate that aninjection device 10 has expired.

The processor arrangement 230 may be configured to check the state ofcharge of one or more batteries 170 included in the packaging assembly100. The state of charge is determined to be low if it is below athreshold (which may be built into the design of the packagingarrangement). The state of charge may be determined by measurement ofthe voltage provided by the battery 170, by monitoring energy use from afull state of charge, or a combination of these two techniques.

The electronics system 200 comprises a fridge open sensor 251. Thefridge open sensor 251 may be a light sensor, for example aphototransistor, mounted on the electronics system 200. The fridge opensensor 251 is configured to provide a signal to the processorarrangement 230 when light is incident on the phototransistor. Forexample, when the packaging assembly 100 is stored within a fridge, thefridge open sensor 251 may provide an indication that a door of thefridge is open by providing a signal when ambient light from outside thefridge, or light from an internal fridge light, is incident on thephototransistor. When the fridge door is closed, no light is incident onthe phototransistor and the fridge open sensor 251 provides no signal ora small signal.

The fridge open sensor 251 may comprise a phototransistor configured topass a current according to the amount or intensity of light which isincident on the phototransistor. The fridge open sensor 251 may beconfigured to provide a signal of one type (e.g. high) when an intensityof incident light exceeds a threshold, and a signal of an opposite type(e.g. low) when an intensity of incident light is below the threshold.

Alternatively, the fridge open sensor 251 provides a current signal tothe processor arrangement 230 according to the intensity of light whichis incident on the phototransistor. The received signal may be comparedto a threshold by the processor arrangement 230. The threshold may be apreset threshold stored in the non-volatile memory 233, or it may bedynamically adjustable having regard to operating conditions.

The processor arrangement 230 is configured to determine whether a doorof a fridge in which the packaging assembly 100 is stored is open orclosed, based on a signal received from the fridge open sensor 251.

The processor arrangement 230 is configured to start a door timer whenthe fridge door is opened. The processor arrangement 230 starts the dooropen timer in response to a signal from the light sensor 251 to indicatethat the fridge door is open. The signal from the light sensor 251 maybe used to trigger an interrupt port input to the processor arrangement230. After the timer has been started, the device can be said to be in adoor open state. When the fridge door is closed, the device can be saidto be in a door closed state.

The processor arrangement 230 may be configured to enter a partial sleepstate when the time period measured by the door timer is over athreshold time. For example, the processor arrangement 230 may enter apartial sleep state when the fridge door has been open for 5 minutes.The door open timer may be configured to expire after a predeterminedtime, for instance in the range of 1 minute to 10 minutes. The processorarrangement 230 may control the electronics system 200 not to generatean output in the partial sleep state. In the door closed state and inthe partial sleep state the processor arrangement 230 changes to thestand-by clock speed to reduce power usage.

The device transitions from the door open state to the partial sleepstate when the door timer passes the 5 minutes mark. The door timer maybe started at 5 minutes when the door is detected to be opened and countdown such that the timer expires if the door is not closed within 5minutes.

The electronics system 200 comprises a lid open sensor. The lid opensensor 252 is configured to provide a signal to the processorarrangement 230 when the lid 120 of the case 110 in a closed position.

The lid open sensor 252 may be a hinge switch, for example anelectro-mechanical switch such as a microswitch or other miniature snapaction switch. The lid open sensor 252 may be arranged to mechanicallyengage with the lid 120 when the lid 120 is in a closed position. Anactuating part 128 of the lid 120 may be shaped to engage with the lidopen sensor 252 when the lid 120 is in a closed position. The lid opensensor 252 may be a normally open switch having an open state and aclosed state. The switch may be operated to move from the open state tothe closed state when pressed. The switch may be configured to pass acurrent in a closed state only.

The lid open sensor 252 may be configured to provide a signal to theprocessor arrangement 230 when the switch is pressed into the closedstate by the lid 120. The processor arrangement 230 may be configured toset a variable to indicate whether or not the lid 120 has been opened.The processor arrangement 230 may store a lid flag. The processorarrangement 230 may set the lid flag to have a value of 1 when the lidopen sensor 252 indicates that the lid 120 has been opened.

The electronics system 200 comprises a sensor array 240. The sensorarray 240 is arranged to detect one or more injection devices 10inserted into or removed from the packaging assembly 100. The sensorarray 240 is configured to detect whether or not an injection device 10is moved through each of the openings 151. The sensor array 240 providesa signal to the processor arrangement 230 to indicate the presence of aninjection device 10 in each of the openings 151. The processorarrangement 230 stores a device table in the volatile memory 232 whichrecords whether or not an injection device 10 is stored in each of theopenings 151.

The sensor array 240 comprises a plurality of device sensors 241. Thenumber of device sensors 241 in the sensor array 240 corresponds to thenumber of injection devices 10 which can be stored in the packagingassembly 100. The sensor array 240 comprises one device sensor 241 foreach of the openings 151.

A device sensor 241 comprises a radio-frequency (RF) antenna mounted inproximity to the corresponding opening 151. The processor arrangement230 operates the device sensor 241 to transmit an RF electromagneticsignal through the antenna. When an injection device 10 is located atthe opening 151, the electromagnetic signal activates a device tag 30 onthe injection device 10. The device tag 30 comprises an RF antenna and alow power circuit. The device tag 30 is powered through induction by theRF signal broadcast by the device sensor 241.

The device tag 30 is arranged at a midpoint on the length of theinjection device 10. The device tag 30 is activated when the midpoint ofthe injection device 10 passes through the opening 151. When activated,the device tag 30 transmits a response signal through the RF antenna.The device sensor 241 detects the response signal transmitted by thedevice tag 30 and provides a signal to the processor arrangement 230.The processor arrangement 230 determines whether the injection device 10is being inserted into the opening 151 or removed from the opening 151,according to the information in the device table. The processorarrangement 230 updates the device table according to whether theinjection device 10 is being inserted into the opening 151 or removedfrom the opening 151.

The device sensor 241 may receive device information from the device tag30. The device tag 30 may comprise a non-volatile storage with storeddevice information. The device tag 30 may be configured to transmit thedevice information with the response signal when activated by the devicesensor 241. The device tag 30 may store one or more of a device ID, adevice type, an expiry date, a dosing time period and a warm-up timeperiod for the injection device 10. The device sensor 241 may receivethe device information transmitted with the response signal from thedevice tag 30. The device sensor 241 sends the received deviceinformation to the processor arrangement 230.

The sensor array 240 is operated by the processor arrangement 230 toscan for one or more injection devices 10 when the lid 120 is open andthe packaging assembly 100 is in usual working mode. The processorarrangement 230 updates the device table based on device informationreceived from the sensor array 240.

The processor arrangement 230 receives device information for eachinjection device 10 inserted into or removed from the packaging assembly100. The processor arrangement 230 is configured to store receiveddevice information in the volatile memory 232. The received deviceinformation is stored in the volatile memory 232 in a device table. Anexemplary device table is shown below in Table 1.

TABLE 1 device information stored in volatile memory Device DeviceDevice Dosing Expiry Device ID Type Index Period Date Expired 1 #213451#0001 01 28 days DDMMYYYY 2 #234534 #0001 02 28 days DDMMYYYY 3 #467655#0002 01 14 days DDMMYYYY 4 #567567 #0002 02 14 days DDMMYYYY Y 5#643544 #0002 03 14 days DDMMYYYY Y 6 NULL

The processor arrangement 230 stores the device ID, device type, dosingtime period and expiry date received from each device tag 30 in thedevice table. The device table includes an entry for each injectiondevice 10 stored in the packaging assembly 100. The processorarrangement 230 records a NULL entry for each empty position in thepackaging assembly 100.

The device ID represents a unique identifier for the injection device10. Each injection device 10 has a unique device ID recorded on thedevice tag 30. The device type is related to the specific treatmentprovided by the injection device 10. The device type may be defined byany feature which differentiates injection devices 10 for differenttreatments. For example, the device type may be defined by one or moreof the medicament contained in each injection device 10, the volume orconcentration of the medicament and the method of administration. Thedevice type may be represented by one field in the device table or,alternatively, may be represented by two or more distinct fields.

The processor arrangement 230 records a device index for each injectiondevice 10. The device index relates to the number of injection devices10 of each type stored in the packaging assembly 100. Injection devices10 of the same type are assigned distinct numerical device indices insequence by the processor arrangement 230. The highest device index fora certain device type in the device table indicates the number ofinjection devices 10 of the certain type stored in the packagingassembly 100. The processor arrangement 230 may separately record thedevice index for each device type. The device index for a device type is“0” when no injection device 10 of that type is stored in the packagingassembly 100.

The device ID may be validated by the processor arrangement 230. Theprocessor arrangement 230 may operate the user interface 210 to output avisual indication if a device ID is not recognised by the processorarrangement 230.

If a new device type of injection device 10 is detected by the sensorarray 240, the processor arrangement 230 initiates a new countdown timerbased on the dosing time period for that device type. If a countdowntimer is not active for a device type of injection device 10, forexample, if the device type is newly introduced to the packagingassembly 100, or if a previous countdown timer for that device type hasbeen removed, a new countdown timer is initiated based on the dosingtime period for the device type.

If an active countdown timer is determined to be redundant, theprocessor arrangement 10 removes the redundant countdown timer. Forexample, if an injection device 10 is removed and the treatment is nolonger going to be continued, the processor arrangement 10 is configuredto remove the redundant countdown timer. When the active countdown timereaches zero, the processor arrangement 10 is configured to check thedevice index and determine whether an injection device 10 of the correcttype is stored in the packaging assembly 100. If no injection device 10of the correct time is stored in the packaging assembly 100, thecountdown timer is removed. In this way, after the final injectiondevice 10 is used, the active countdown timer is not removed until theexpiry of one full countdown cycle, and may be continued if the correcttype of injection device 10 is replenished before the countdown timerreaches zero.

The dosing time period for a type of injection device 10 represents theperiod of time required between each scheduled dosing time for thedevice type. The dosing time period for each injection device 10 may berecorded on the device tag 30 and transmitted to the device sensor 241.Alternatively, a dosing time period for one or more types of injectiondevice 10 may be stored in the non-volatile memory 233 of theelectronics system 200. The processor arrangement 230 may record thedosing time period for an injection device 10 in the device table basedon the device information received from the device sensor 241.

The processor arrangement 230 generates an active countdown timer foreach type of injection device 10 stored in the packaging assembly 100.Each active countdown timer is a countdown operation performed by theprocessor arrangement 230 as described above. The countdown time foreach device type is initiated with the number of days specified by thedosing time period.

The expiry date of an injection device 10 represents the latest date onwhich the injection device 10 is considered suitable for use. When theexpiry date is in the past the injection device 10 is considered to beexpired and should not be used. The processor arrangement 230 records anexpired flag when the expiry date of an injection device 10 is in thepast.

Alternatively, the processor arrangement 230 may compare the expiry dateof an injection device 10 with the next scheduled dosing time for theinjection device 10. The processor arrangement 230 may already record anexpired flag when the expiry date of the injection device 10 will passbefore the next scheduled dosing time becomes due. The processorarrangement 230 may be further configured to record an expired flag ifthe injection device 10 is not suitable for use for any other reason.For example, if the internal temperature of the packaging assembly 100is recorded as being too high for a predefined period of time, theprocessor arrangement 230 may record an expired flag for one or moreinjection devices 10 stored therein.

The electronics system 200 comprises a reset switch 215. The resetswitch 215 is configured to provide a signal to the processorarrangement 230 when actuated by the reset button 164. The user pressesthe reset button 164 to indicate that an injection device 10 has beenremoved from the packaging assembly 100 and the medicament has beenadministered.

The reset switch 215 may be a mechanical switch mounted on theelectronics system 200. The reset switch 215 is arranged to be actuatedby the reset button 164. The reset switch 215 may be a normally openswitch having an open state and a closed state. The reset switch 215 maybe operated to move from the open state to the closed state whenpressed. The reset switch 215 may be configured to pass a current in aclosed state only. The reset switch 215 may be configured to provide asignal to the processor arrangement 230 when moved to the closed state.

The reset button 164 may be coupled to the reset switch 215. The resetswitch 215 may be positioned below the reset button 164. If the resetbutton 164 is pressed, the reset switch 215 may be moved to the closedstate by the reset button 164. The reset switch 215 is configured toprovide a signal to the processor arrangement 230 when actuated by thereset button 164. The processor arrangement 230 may set the lid flag tohave a value of 0 when the reset button 164 is pressed.

The processor arrangement 230 is configured to operate a reset timer.The processor arrangement 230 is configured to reset the time period forthe next scheduled dosing time when the time period measured by thereset timer is over 2 seconds. The reset timer is started from zero whenthe reset switch 215 is moved to the closed state. Alternatively, thereset timer may be started at 2 seconds when the reset switch 215 isclosed and count down such that the timer expires if the reset switch isnot opened within 2 seconds.

The user must press and hold the reset button 164 for 2 seconds tomaintain the reset switch 215 in the closed state for 2 seconds. Theprocessor arrangement 230 filters out short presses of the reset button164, so as to reduce the occurrence of falsely triggering the resetoperation.

The electronics system 200 comprises the display 211 of the userinterface 210. The display 211 can be operated to provide anotification. The display 211 can be operated to provide an indicationof a status of the packaging assembly 100. The display 211 is an exampleof a status indicator. The display 211 can be operated to showinformation relating to the status of the packaging assembly 100. Thedisplay 211 can be operated to show any number from 00 to 99 byilluminating some or all of the LED segments. Certain letters may alsobe shown by the display 211.

The electronics system 200 may comprise a display driver 235. Thedisplay driver 235 may be provided as a separate integrated circuit chipto the processor arrangement 230, which is connected by an off-chip bus.Alternatively, the display driver 235 may be provided on a singleintegrated circuit chip with the processor arrangement 230. The displaydriver 235 may be a port expander for individually controlling thesegments of a seven-segment LED display.

The processor arrangement 230 can operate the display 211 to show thenumber of days remaining until the next scheduled dosing time is due.The processor arrangement 230 is configured to determine the lowestactive countdown timer, that is, the countdown timer with the fewestdays remaining. The display 211 can be operated to show the number ofdays remaining on the lowest active countdown timer. The display 211 canbe operated to provide a visual reminder output that the next scheduleddosing time is due. The display 211 can be operated further to provide avisual reminder output that the next scheduled dosing time is near.

For example, the processor arrangement 230 may start a new activatecountdown timer from 14 days. If the countdown timer is the lowest, oronly, active countdown timer, the display 211 is operated to show thenumber “14” to indicate that 14 days remain. Each day, the number ofdays shown by the display 211 is reduced by one. After 13 days, when 1day remains until the scheduled dosing time, the display 211 is operatedto show “01”. The display 211 is operated to flash or blink to indicatethat the scheduled dosing time is near. The display 211 is operated toflash by intermittently showing “01”.

On the day of the scheduled dosing time, the display 211 is operated toshow “00”. The display 211 is operated to flash to indicate that thescheduled dosing time is due. The display 211 is operated to flash byintermittently showing “00”. The flash periodicity of the display 211may be of the order of 0.25 seconds to 2 seconds.

The processor arrangement 230 may check the state of charge of one ormore batteries 170 included in the packaging assembly 100. If the stateof charge is determined to be low, the display 211 may be operated toshow a battery low warning.

The battery low warning shown by the display 211 may be a messagecomprising an upper case L on the first seven-segment array, and a lowercase o on the second seven-segment array. That is, the display 211 mayshow the message “Lo”. The battery low warning may be shownintermittently by the display 211 under the control of the processorarrangement 230. The display 211 may be operated to show the battery lowwarning alternately with the number of days remaining until thescheduled dosing time. The periodicity of the intermittent oralternating operation of the display 211 may be of the order of 0.25seconds to 2 seconds

The electronics system 200 comprises the LED array 220 of the userinterface 210. The LED array 220 can be operated to provide anotification. LED array 220 can be operated to provide an indication ofa status of the packaging assembly 100. The LED array 220 is an exampleof a status indicator.

The processor arrangement 230 can operate the LED array 220 to provide avisual reminder that a scheduled dosing time is due. On the day of ascheduled dosing time, the LED array 220 is operated to generate avisual reminder output. The processor arrangement 230 can operate theLED array 220 to provide a visual indication that an injection device 10is expired. The processor arrangement 230 can operate the LED array 220to provide a visual indication that an injection device 10 is notlocated in one of the openings 151. The processor arrangement 230 canoperate the LED array 220 to provide a visual indication that the statusof an injection device 10 is normal.

The LED array 220 comprises an array of eighteen light-emitting diodes(LEDs). The LEDs of the LED array 220 are arranged on the panel 150, inproximity to the openings 151. The LED array 220 comprises three LEDs221,222,223 for each of the six openings 151. Each of the three LEDs221,222,223 can be illuminated with a different colour. For example, theLED array 220 may comprise a blue LED 221, a white LED 222 and a red LED223 for each opening 151.

The white LED 222 corresponding to an opening 151 is operated to providea visual indication that the opening 151 is empty. When the devicesensor 241 does not detect an injection device 10 located in the opening151, the processor arrangement 230 records a value of NULL for thedevice ID in the device table. The white LED 222 is activated by theprocessor arrangement 230 when the corresponding entry in the devicetable has the value of NULL for the device ID.

The red LED 223 corresponding to an opening 151 is operated to provide avisual indication that the injection device 10 located in the opening151 has expired. The red LED 223 is activated by the processorarrangement 230 when the corresponding entry in the device table has anexpired flag.

The blue LED 221 corresponding to an opening 151 is operated to flash orblink to provide a visual reminder that the scheduled dosing time is duefor the injection device 10 stored in the opening 151. When an activecountdown timer indicates that a scheduled dosing time is due, theprocessor arrangement determines the device type associated withcountdown timer. The processor arrangement 230 identifies the injectiondevice 10 of the correct device type which has the earliest expiry date.If the identified injection device 10 is expired, the processorarrangement 230 determines the injection device 10 with the nextearliest expiry date, until an injection device 10 is identified whichis not expired. If the processor arrangement 230 identifies a pluralityof injection devices 10 having the same device type and the same expirydate, then the injection device 10 having the lowest device index isidentified. The processor arrangement 230 operates the blue LED 221corresponding to the identified injection device 10 to flash or blink.The flash periodicity of the blue LED array 221 may be of the order of0.25 seconds to 2 seconds.

The blue LED 221 corresponding to an opening 151 is operated to providea visual indication that the injection device 10 located in the opening151 has a normal status. If the injection device 10 is not expired, anda scheduled dosing time is not due, the blue LED 221 is illuminatedcontinuously.

The electronics system 200 comprises the speaker 213 of the userinterface 210. The speaker 213 can be operated to output a notificationsignal. The speaker 213 can be operated to provide an indication of astatus of the packaging assembly 100. The speaker 213 is an example of astatus indicator.

The processor arrangement 230 operated the speaker 213 to provide anaudio reminder that the next scheduled dosing time is due. On the day ofa scheduled dosing time, the speaker 213 is operated to output an audioreminder that the schedule dosage time is due. The speaker 213 may beoperated to output an intermittent tone or tone sequence. Theperiodicity of the intermittent speaker 213 output may be of the orderof 0.25 seconds to 2 seconds.

The processor arrangement 230 controls the operation of the speaker 213according to the signal input by the lid open sensor 252. The processorarrangement 230 may control the operation of the speaker 213 accordingto the stored value of the lid flag. When the scheduled dosing time isdue, the processor arrangement 230 operated the speaker 213 to output anaudio indication that the scheduled dosing time is due, as describedabove. When the lid open sensor 252 provides a signal to the processorarrangement 230 to indicate that the lid 120 of the case 110 is open,the processor arrangement 230 controls the speaker 213 to deactivate thereminder.

When the lid open sensor 252 provides a signal to the processorarrangement 230 to indicate that the lid 120 is open, the processorarrangement 230 sets the lid flag to have a value of 1. The processorarrangement 230 controls the speaker 213 to deactivate the reminder whenthe stored value of the lid flag is equal to 1. The processorarrangement 230 resets the lid flag to have a value of 0 when the resetbutton 164 is pressed, so that the speaker 230 is activated when thenext scheduled dosing time is due.

In this way, the audio reminder output by the speaker 213 is deactivatedonly when the lid opened by a user. The speaker 213 is deactivated onlywhen the user opens the lid 120 of the case 110 to retrieve theinjection device 10 for the scheduled dosage. The packaging assembly 100thereby improves compliance with the scheduled dosage regime.

The processor arrangement 230 controls the display 211, LED array 220and the speaker 213 according to an input from the fridge open sensor251. If the fridge open sensor 251 indicated by signalling to theprocessor arrangement 230 that the fridge door is open, the processorarrangement 230 controls the display 211, LED array 220 and the speaker213, as described above. If the fridge open sensor 251 does not indicateby signalling to the processor arrangement 230, the processorarrangement 230 does not activate the display 211, LED array 220 or thespeaker 213.

In this way, the display 211, the LED array 220 and the speaker 213 arenot active when the fridge is closed. The user interface 210 of thepackaging assembly 100 is activated only when the fridge is open,therefore conserving the energy of the battery 170.

The processor arrangement 230 is configured to start the door timer fromzero when the fridge door is opened. After the timer has been started,the device can be said to be in a door open state. The processorarrangement 230 is configured to enter a partial sleep state when thetime period measured by the door timer is over 5 minutes. The display211, LED array 220 and the speaker 213 are turned off by the processorarrangement 230 in the partial sleep state, and the processorarrangement operates at the stand-by clock speed.

With respect to FIG. 7, a flowchart showing a second exemplary operationof the packaging assembly 100 is shown. The second exemplary operationof FIG. 7 supplements the first exemplary operation of FIG. 5. Thesecond exemplary operation of FIG. 7 shows the first exemplary operationof FIG. 5 in a different manner, and includes more detail.

The Process Starts at Step 7.1.

At step 7.2, the processor arrangement 230 checks whether or not thefridge door is open. The processor arrangement 230 checks whether asignal to indicate that fridge door is open is received from the fridgeopen sensor 251. If a signal is not received, the processor arrangement230 proceeds to step 7.3. At step 7.3 the processor arrangement 230waits 0.5 seconds before returning to step 7.2 and checking againwhether or not the fridge is open. If a signal indicating that thefridge door is open is received by the processor arrangement 230, theprocessor arrangement 230 proceeds to step 7.4. At step 7.4, theprocessor arrangement 230 starts a timer to monitor for how long thefridge door has been open.

At step 7.5, the processor arrangement 230 determines whether or not thelid 120 is open by checking whether or not a signal is received from thelid open sensor 252 to indicate that the hinge switch 252 is pressed bythe actuating part 128 of the lid 120. If the processor arrangement 230determines that the lid 120 is not open, the processor arrangement 230proceeds to step 7.26. Otherwise, if the processor arrangement 230determines that the lid 120 is open, the processor arrangement 230proceeds to step 7.6.

At step 7.6, the processor arrangement 230 checks each of the devicesensors 241 for the presence of an injection device 10. The processorarrangement 230 operates the sensor array 240 to determine whether ornot a device tag 30 is located in proximity to any of the device sensors241. An RF signal is transmitted by each of the plurality of devicesensors 241. The processor arrangement 230 receives a signal from thesensor array 240 if a response signal is detected by a device sensor241. In this case, the processor arrangement 230 proceeds to step 7.7.The processor arrangement 230 receives device information from thesensor array 240 if device information is received by a device sensor241. If no signal is received from the sensor array 240, the processorarrangement proceeds to step 7.12.

At step 7.7, the processor arrangement 230 checks the device informationreceived from the sensor array 240. The processor arrangement 230 checksthe device ID for the detected injection device 10. If the receiveddevice ID is already stored in the device table, the processorarraignment 230 determines that the injection device 10 is being removedfrom the packaging assembly 100, and proceeds to step 7.8.

At step 7.8, the processor arrangement 230 updates the device tablebased on the removal of the injection device 10. If necessary, theprocessor arrangement 230 updates the device index for any injectiondevices 10 of the same device type. A device index for an injectiondevice 10 may be reduced by 1 to replace an injection device which hasbeen removed from the packaging assembly 100. The processor arrangement230 further records a value of NULL in the device ID field for the entryof the device table corresponding to the removed injection device 10.

If the processor arrangement 230 determines at step 7.7 that thedetected injection device 10 has a new device ID, the processorarrangement 230 proceeds to step 7.9.

At step 7.9, the processor arrangement 230 stores the device ID anddevice type for the injection devices 10 detected by the sensor array240. The processor arrangement 230 receives the device ID and devicetype of the injection device 10 from the sensor array 240 and recordsthe received device ID and device type in the volatile memory 232. Thereceived device ID and device type for each opening 151 is recorded inthe corresponding entry of the device table stored in the volatilememory 232.

At step 7.10, the processor arrangement 230 records device indices forentries in the device table which do not have a device index. A deviceindex is generated and stored for each injection device 10 which isnewly added to the packaging assembly 100. The device index is generatedaccording to the device type of injection device 10, according to thenumber of injection devices 10 of the same device type which are alreadystored in the packaging assembly 100.

At step 7.11, the processor arrangement 230 creates a new timer for eachnewly added device type of injection device 10. The processorarrangement 230 checks the device type for each entry in the devicetable and, for each device type, checks that a corresponding countdowntimer is active. For any device type which does not have an activecountdown timer, the processor arrangement initiates a new countdowntimer. A new countdown timer is initiated based on the time period forthe device type stored in the device table.

At step 7.12, the processor arrangement 230 checks whether or not thereset button 164 has been pressed. The processor arrangement 230 isconfigured to reset the countdown timer to the scheduled dosing timeonly if the reset button 164 is held down for two seconds or more. Ifthe processor arrangement 230 detects that the reset button 164 has beenpressed, the processor arrangement 230 proceeds to step 7.13. At step7.13, the processor arrangement 230 starts a reset timer to monitor forhow long the reset button 164 has been pressed.

After starting the timer, the processor arrangement 230 proceeds to step7.14 and waits 0.5 seconds. At step 7.15, the processor arrangement 230operates the display 211 to flash on and off with the current number ofdays. Alternatively, the display 211 may show alternately the currentnumber of days and a message to indicate that the reset operation is tobe initiated. For example, the display 211 may show the message “—”. Ifthe reset button 164 is pressed at a scheduled dosing time, the display211 shows “00” and “—” alternately. Further alternatively, the display211 may alternately show the current number of days and the number ofdays in the dosing period for the countdown timer which is to be resete.g. the display may show “00” and “14” alternately.

At step 7.16, the processor arrangement 230 checks whether or not thereset timer is over two seconds. If the reset timer is below twoseconds, the processor arrangement 230 proceeds to step 7.17. At step7.17, the processor arrangement 230 checks whether or not the resetbutton has been released.

If the reset button 164 is found to have been released before the resettimer has reached two seconds, then the processor arrangement 230continues with the normal operation at step 7.23. If the reset button164 has not been released, then the processor arrangement 230 returns tostep 7.14 and waits 0.5 seconds before again checking the reset timer atstep 7.16.

If the processor arrangement 230 finds that the reset timer is over twoseconds, the processor arrangement 230 carries out a reset operationbeginning with step 7.18. At step 7.18, the processor arrangement 230operates the speaker 213 to output a short alert sound, to indicate tothe user that the reset operation has been initiated.

At step 7.19, the processor arrangement 230 resets the countdown timerif it is completed. If multiple countdown timers are active andcompleted at the same time, the processor arrangement 230 may reset thecountdown timer corresponding to the device type of the most recentlyremoved injection device 10. The countdown timer is reset based on thetimer period for the device type stored in the device table.

At step 7.20, the processor arrangement 230 operates the display 211 toshow the number of days remaining for the lowest active countdown timer.The processor arrangement 230 checks each active countdown timer todetermine which countdown timer has the fewest days remaining untilexpiry.

At step 7.21, the processor arrangement 230 checks whether or not thereset button 164 has been released. If the reset button 164 has been notbeen released, the processor arrangement 230 proceeds to step 7.22, andwaits 0.5 seconds. The processor arrangement 230 then returns to step7.21 and again checks whether or not the reset button 164 has beenreleased. When the reset button 164 is determined to have been released,the processor arrangement 230 continues with the normal operation atstep 7.23.

At step 7.23, the processor arrangement 230 checks the expiry conditionfor each injection device 10 stored in the packaging assembly 100. Foreach entry in the device table, the processor arrangement 230 checks thestored expiry date. If the stored expiry date is in the past, theprocessor arrangement 230 determines that the corresponding injectiondevice 10 has expired.

At step 7.24, the processor arrangement 230 sets an expired flag foreach expired injection device 10. The expired flag is recorded in thedevice table for each injection device 10 which is determined to beexpired in step 7.23.

Alternatively, the processor arrangement 230 may compare the expiry dateof an injection device 10 with the next scheduled dosing time for theinjection device 10. The processor arrangement 230 may determine thatthe injection device 10 will expire before the next scheduled dosingtime is due. The processor arrangement 230 may record an expired flagwhen the expiry date of the injection device 10 will pass before thenext scheduled dosing time.

At step 7.25, the processor arrangement 230 controls the LED array 220for each opening 151 according to the corresponding entry in the devicetable. If an entry in the device table shows an expired flag, theprocessor arrangement 230 operates the LED array 220 to activate the redLED 223. If the device ID of an entry in the device table shows that theopening 151 is empty, the processor arrangement 230 operates the LEDarray 220 to activate the white LED 222. The processor arrangement 230operates the LED array 220 to activate the blue LED 221 for each opening151 which contains an injection device 10 which is not expired. Wherethe condition of an injection device 10 is normal, the blue LED 221 isactivated with a constant illumination.

At step 7.26, the processor arrangement 230 checks whether or not thebattery 170 is low. If the battery 170 has a low state of charge, theprocessor arrangement 230 operates the user interface 210 to indicatethis to the user.

The state of charge is determined to be low if it is below a definedthreshold. The threshold may be built into the design of the packagingarrangement. The state of charge may be determined by measurement of thevoltage provided by the battery 170, by monitoring energy use from afull state of charge, or a combination of these two techniques.

At step 7.27, the processor arrangement 230 operates the display 211 toshow a battery low warning message alternately with the number of dayson the countdown.

The battery low warning shown by the display 211 comprises an upper caseL on the first seven-segment array, and a lower case o on the secondseven-segment array. That is, the display 211 shows the message “Lo”.For example, if the number of days on countdown to the scheduled dosingtime is zero days, so the display 211 shows alternately the message “Lo”and the number zero (“00”).

If the battery 170 does not have a low state of charge, the processorarrangement 230 checks the status of the lowest active countdown timer.First, at step 7.28, the processor arrangement 230 checks whether thecountdown has reached zero days. If not, the processor arrangement 230proceeds to step 7.29. At step 7.29, the processor arrangement 230checks whether the countdown is at one day. If the countdown is not atzero days or one day, then the processor arrangement 230 determines thatthe countdown to the scheduled dosing time is greater than one day.

If the countdown to the schedule dosing time is zero days, then theprocessor arrangement 230 determines that the scheduled dosing time isdue.

At 7.30, the processor arrangement 230 checks that the active countdowntimer that has reached zero is still required. Where the scheduleddosing time for a certain device type is due, the processor arrangement230 checks that at least one injection device 10 of that type is storedin the packaging assembly 100. The processor arrangement 230 checks thedevice indices stored for the device type in the device table. If noinjection device 10 of the correct type is stored in the packagingassembly 100 the device index is “0”. If the device index is “0” formore than the full countdown timer period for that device type, theprocessor arrangement 230 proceeds to step 7.31, and removes thecountdown timer. If the device index at step 7.30 is not “0”, theprocessor arrangement 230 proceeds to step 7.32.

At step 7.32, the processor arrangement 230 determines whether or notthe lid 120 is open by checking whether or not a signal is received fromthe lid open sensor 252 to indicate that the hinge switch 252 is pressedby the actuating part 128 of the lid 120. If the processor arrangement230 determines that the lid 120 is not open, the processor arrangement230 proceeds to step 7.33.

At step 7.33, the processor arrangement 230 checks whether or not thestored value of the lid flag is equal to 1. The lid flag indicateswhether or not the lid 120 has been opened. If the lid has not beenopened, the value of the lid flag is 0. When the lid flag is not equalto 1, the processor arrangement 230 determines that the lid 120 has notbeen opened. When the lid flag is not equal to 1, the processorarrangement proceeds to step 7.34. At step 7.34, the processorarrangement 230 operates the speaker 213 to output a notification alertsound. The processor arrangement 230 operates the display 211 to flashthe number of days, that is, zero days

If the lid 120 is opened, the processor arrangement 230 determines atstep 7.32 that the lid 120 is open. At step 7.35, the processorarrangement 230 sets a lid flag to have a value of 1. The lid flagindicates whether or not the lid 120 has been opened.

At step 7.36, the processor arrangement 230 operates the LED array 220to activate the blue LED 221 for an opening 151 which contains aninjection device 10 of the device type due for injection. The processorarrangement 230 determines the device type of injection device 10corresponding to the countdown timer which has reached zero days. Theprocessor arrangement 230 suggests the injection device 10 of thecorrect device type which is closest to expiry. The processorarrangement 230 determines the entry in the device table showing theearliest expiry date for the device type. The processor arrangement 230activates the blue LED 221 for the opening 151 which corresponds to thedetermined entry. The processor arrangement 230 operates the blue LED221 to blink.

If the entry showing the earliest expiry date for the device type isshowing an expired flag, the processor arrangement 230 proceeds to theentry with the next earliest expiry date, until an injection device 10which is not expired is identified. If the processor arrangement 230identifies a plurality of injection devices 10 having the same devicetype and the same expiry date, then the injection device 10 having thelowest device index is identified. If an entry for the device typewithout an expiry flag is not available, the processor arrangement 230may operate the red LED 223 of the corresponding opening 151 to blink.In this way, the user can be informed of the type of injection device 10which is due for injection, when all of the stored injection devices 10of this type have expired.

At step 7.37, the processor arrangement 230 deactivates the speaker 213.The processor arrangement 230 operates the display 211 to flash thenumber of days, that is, zero days.

In this way, a notification alert sound output by the speaker 213 can bedeactivated only by the user opening the lid 120 to retrieve therequired injection device 10. The packaging assembly 100 therebyimproves compliance with the dosage regime.

If the lid 120 is closed, and the processor arrangement 230 determinesat step 7.33 that the value of the lid flag is equal to 1, then theprocessor arrangement proceeds to step 7.37. At step 7.37, the processorarrangement 230 deactivates the speaker 213. The speaker 213 remainsdeactivated if the lid 120 is closed again after being opened.

If the number of days until the scheduled dosing time is one day, theprocessor arrangement 230 proceeds to step 7.38. At step 7.38, theprocessor arrangement 230 operates the display 211 to flash the numberof days on the countdown. In this case, the display 211 flashes “01”.

If the number of days until scheduled dosing time is greater than oneday, the processor arrangement 230 proceeds to step 7.39. At step 7.39,the processor arrangement 230 operates the display 211 to show thenumber of days remaining.

The processor arrangement 230 thereby controls the output of the displayaccording to the number of days remaining until the scheduled dosingtime and according to the state of charge of the battery 170, andoperates the speaker 213 according to whether or not the lid 120 of thecase 110 is open.

After setting the output of the user interface 210, the processorarrangement 230 proceeds to step 7.40 and waits 0.5 seconds. The waitperiod while the fridge door is open may be shorter, to correspond tothe normal processing clock speed when the device is in the door openstate. The wait period and/or clock speed may be set based on therequirements for responsiveness and power consumption.

At step 7.41 the processor arrangement 230 checks whether or not thefridge door is closed. The processor arrangement 230 checks whether thesignal to indicate that the fridge door is open is still being receivedfrom the fridge open sensor 251. If the processor arrangement 230determines the fridge door is open, the processor arrangement 230proceeds to step 7.42.

At step 7.42, the processor arrangement 230 checks the time currently onthe door timer. The processor arrangement 230 checks whether or not thedoor timer is over five minutes. That is, the processor arrangement 230checks whether the door of fridge has been open for more than fiveminutes. If the door of the fridge has been open for a period of lessthan five minutes, then the processor arrangement 230 returns to anearlier point of operation at step 7.5, immediately after the initialpoint of starting the door timer. The processor arrangement 230 againchecks the reset button 164, checks the countdown until the scheduleddosing time, checks the state of charge of the battery 170, and checksthe state of the lid 120 before setting the output of the user interface210.

If the processor arrangement 230 determines that the door of the fridgehas been open for a period longer than five minutes, the processorarrangement 230 controls the user interface 210 to enter a partial sleepstate. At step 7.43, the processor arrangement 230 turns off the LED220, the speaker 213, and the display 211, to conserve power. At step7.44, the processor arrangement 230 checks again whether or not thefridge door has been closed. If the processor arrangement 230 determinesthat the fridge door is open, the processor arrangement 230 proceeds tostep 7.45 and waits 0.5 seconds before returning to step 7.43.

If the processor arrangement 230 determines at step 7.44 that the fridgedoor has been closed, the processor arrangement 230 proceeds to step7.46. At step 7.46, the processor arrangement 230 turns off the LED 220,the display 211 and the speaker 213. At step 7.47, the processorarrangement 230 sets the lid flag to have a value of 0, before returningto step 7.3, At step 7.3, the processor arrangement 230 waits 0.5seconds before checking whether or not the fridge door has been opened,as described above.

This provides a door open timer that is activated in response to adetermination of an intensity of light sensed by the light sensor risingabove a defined threshold amount of light. The door open timer iscancelled in response to a determination of the intensity of lightsensed by the light sensor falling below the threshold amount of light,which corresponds to the door being closed. If the time expires beforeit is cancelled, it is determined that the fridge door has been leftopen unintentionally and optical and audio alerts and visual indicationsof remaining time to day zero are suppressed. This reduces powerconsumption of the device with relatively little reduction in usefulalerting. Once the fridge door is shut again, normal operation resumes.When subsequently the fridge door is again opened, alerting andindication occurs as usual in the door open mode.

A first exemplary user operation of the packaging assembly 100 will nowbe described with respect to FIG. 8.

The Operation Starts at Step 8.1.

At step 8.2, the user receives the packaging assembly 100. The packagingassembly 100 may be empty. The packaging assembly 100 may include one ormore batteries 170. Alternatively, the user may insert batteries 170into the battery opening 145.

At step 8.3, the mounting plate 190 is fixed to an internal surface ofthe fridge using the adhesive strips 191.

At step 8.4, the case 110 of the packaging assembly 100 is attached tothe mounting plate 190 by magnets 148. The empty packaging assembly 100may be placed in the fridge until the internal temperature of the case110 has been cooled to reach the temperature of the fridge.

At step 8.5, the user receives a plurality of injection devices 10. Theuser may receive up to six injection devices 10, of any type, forstorage in the packaging assembly 100.

At step 8.6, the user places the injection devices 10 into the openings151 of the packaging assembly 100. As each injection device 10 isinserted into an opening 151, the device sensor 241 corresponding to theopening 151 detects the device tag 30 of the injection device 10. Thesensor array 240 receives the device information from the newly insertedinjection device 10 and updates the device table accordingly.

An active countdown timer is set by the processor arrangement 230 foreach new device type of injection device 10 inserted into the packagingassembly 100. The time period for each active countdown time is setaccording to the device type. The user can now use the fridge as normaluntil the next scheduled dosing time is due.

When the next scheduled dosing time is due, the user is provided with areminder alert upon opening the fridge. The user may be provided with avisual reminder alert. The user may be provided with an audio reminderalert.

At step 8.7, in response to the reminder alert, the user removes aninjection device 10 from the packaging assembly 100. The audio reminderalert is deactivated when the lid 120 of the packaging assembly 100 isopened.

At step 8.8, the user administers the medicament using the injectiondevice 10.

At step 8.9, the user holds the reset button for at least 2 seconds. Theprocessor arrangement 230 resets the active countdown timer which hasreached zero, and the reminder alert is deactivated.

At step 8.10, the user checks the number of injection devices 10remaining in the packaging assembly 100. If there is at least oneinjection device 10 in the packaging assembly 100, the user returns tostep 8.7. The user continues to use the fridge as normal until the nextscheduled dosing time is due.

If there are no injection devices 10 remaining in the packaging assembly100, at step 8.11, the user determines whether the therapy is to becontinued. If yes, the user obtains or receives a further batch ofinjection devices 10, and the operation continues from step 8.5. If not,the operation finishes at step 8.12. When the next scheduled dosing timeis due, if the packaging assembly 100 has not been refilled, theprocessing arrangement 230 removes the active countdown timer and theoperation terminates.

With respect to FIG. 9, a flowchart showing a second exemplary useroperation of the packaging assembly 100 is shown. The second exemplaryuser operation of FIG. 9 supplements the first exemplary user operationof FIG. 8. The second exemplary user operation of FIG. 9 shows a part ofthe first exemplary user operation of FIG. 8 in a different manner, andincludes more detail.

The Operation Starts at Step 9.1.

At step 9.2, the user opens the fridge door. The user may open thefridge door specifically to check the packaging assembly 100, or as partof their daily routine. The user may be taking food from the fridge orplacing food into the fridge.

If the number of days remaining on the lowest active countdown timer isgreater than 1 day, then the countdown timer is not equal to 0 days atstep 9.3 and the operation proceeds to step 9.4, The lowest activecountdown timer is not equal to 1 day and the operation proceeds furtherto step 9.5.

At step 9.5, the display 211 shows the number of days remaining untilthe next scheduled dosing time. The user can see the static blue lightof the display 211 through the translucent lid 120. The user can readthe display through the viewing window 121. The display 211 shows thenumber of days remaining on the lowest active countdown timer. Thenumber of days is shown until the user closes the fridge door at step9.17. For the purpose of this illustration, it is assumed that the usercloses the fridge door within 5 minutes of it being opened, so thedisplay and audio alert suppression is not provided.

If the number of days remaining until the next scheduled dosing time is1 day, then the lowest active countdown timer will be determined to beequal to 1 day at step 9.4, and the operation proceeds to step 9.6.

At step 9.6, the display 211 flashes the number of days remaining untilthe next scheduled dosing time. That is, the display 211 flashes “01”.The user can see the flashing blue light of the display 211 through thetranslucent lid 120. The user can read the display 211 through theviewing window 121. The number “01” is flashed until the user closes thefridge at step 9.17.

If the number of days remaining until the next scheduled dosing time is0 days, then the lowest active countdown timer will be determined to beequal to 0 days at step 9.3, and the operation proceeds to step 9.7.

At step 9.7, the display 211 flashes the number “00” and the speaker 213outputs an intermittent tone or tone sequence. The user can see theflashing blue light of the display 211 through the translucent lid 120.The user can read the display 211 through the viewing window 121. Theuser can hear the intermittent tone or tone sequence output by thespeaker 213.

At step 9.8, the user opens the lid 120 of the packaging assembly 100.

At step 9.9, the speaker 213 is turned off. The speaker 213 is turnedoff in response to the lid 120 being moved from a closed position to anopen position. The blue LED 221 flashes for the opening 151 whichcontains the injection device 10 to be used. The user can see theflashing blue LED 221 and determine which injection device 10 is to beused next.

At step 9.10, the user removes the injection device 10 from thepackaging assembly 100 out of the suggested opening 151. The devicetable is updated according to the device information gained from devicetag 30 of the removed injection device 10.

At step 9.11, the user pushes the reset button 164. The user holds downthe reset button 164.

At step 9.12, the display 211 flashes in response to the reset button164 being pushed, The display may flashes “—” alternately with thecurrent number of days until the scheduled dosing time or,alternatively, the display may flash between e.g. “14” and “00”, asdescribed above.

At step 9.13, after the reset button 164 has been held for 2 seconds,the speaker 213 outputs a simple alert sound and the countdown timer isreset.

At step 9.14, the user releases the reset button 164.

At step 9.15, the display 211 shows the number of days remaining untilthe next scheduled dosing time. The display 211 shows the number of daysremaining on the lowest active countdown timer.

At step 9.16, the user closes the lid 120.

At step 9.17, the user closes the fridge door.

The operation finishes at step 9.18.

With respect to FIG. 10A, a packaging assembly 100 according to anexemplary embodiment is shown. Elements of the electronic system 200 andthe user interface 210 are omitted for visual clarity. Elements notdescribed below are substantially the same as those of the firstembodiment.

The sensor array 240 comprises a single device sensor. The sensor array240 is a radio-frequency identification (RFID) reader comprising aradio-frequency antenna. The sensor array 240 extends across the fullwidth defined by the plurality of openings 151. The sensor array 240 isformed as a wire extending rearwards from the PCB 201 (not shown) andforming a horizontal loop. The sensor array 240 is arranged adjacent tothe base of the case 110, below the plurality of injection devices 10stored in the case. Alternatively, the sensor array 240 may bepositioned above the plurality of injection devices 10. The sensor array240 is arranged at a forward end of the case 110, immediately behind thePCB 201.

The sensor array 240 is arranged to detect a device tag 30 of aninjection device 10 as the injection device 10 is passed through one ofthe openings 151. The sensor array 240 generates an electromagneticfield at a forward end of the case 110, immediately behind the openings151. An injection device 10 passed through any of the plurality ofopenings 151 passes through the field generated by the sensor array 240.A specific opening 151 in the plurality of openings 151 in which theinjection device 10 is inserted can be identified from the signalruntime, the signal from a specific opening further from the PCB willhave a longer signal runtime than that of a specific opening closer tothe PCB. When an injection device 10 is fully in position within thecase 110, the device tag 30 is displaced from the field of the sensorarray 240.

With respect to FIG. 10B, a packaging assembly 100 according to anexemplary embodiment is shown. Elements of the electronic system 200 andthe user interface 210 are omitted for visual clarity. Elements notdescribed below are substantially the same as those of the firstembodiment.

The sensor array 240 comprises a plurality of device sensors 241. Eachof the device sensors 241 is formed as a light gate comprising a lightsource 242 and a photo-detector 243. The light source and photo-detectorare arranged in opposition across one of the openings 151. A light gateis formed across each of the plurality of openings 151. The devicesensors 241 determine whether or not an injection device 10 ispositioned in each opening, according to whether or not the light fromthe light source is received by the photo-detector. The light source maybe, for example, an LED or a laser.

With respect to FIG. 10C, a packaging assembly 100 according to anexemplary embodiment is shown. Elements of the electronic system 200 andthe user interface 210 are omitted for visual clarity. Elements notdescribed below are substantially the same as those of the firstembodiment.

The sensor array 240 comprises a plurality of device sensors 241. Eachof the device sensors 241 is formed as a light gate across each of theplurality of openings 151. The sensor array 240 comprises a single lightsource 245 and a single photo-detector 246. The light source may be, forexample, an LED or a laser. An output optical guide is arranged todirect light emitted by the light source to each of the plurality ofopenings 151. An input optical guide is arranged to direct light fromeach of the plurality of openings 151 to the photo-detector. Each of theinput optical guide and the output optical guide is formed by, forexample, an optical fibre structure.

A light gate is formed across each of the plurality of openings 151. Thedevice sensors 241 determine whether or not an injection device 10 ispositioned in each opening, according to whether or not the light fromthe light source is received by the photo-detector. The input opticalguide may direct the light from each device sensor 241 to a differentpart of the photo-detector, such that the sensor array 240 can determinewhich of the openings 151 is filled, according to the position of thereceived light. Alternatively, the sensor array 240 may determine whichopenings are occupied based on the frequency and/or intensity of thereceived light, based on the optical properties of the output opticalguide and input optical guide. Alternatively the sensor array 240 maydetermine which openings are occupied based on signal chopping. Signalchopping periodically splits the signal so that the light reaches onespecific opening in the plurality of openings 151 at a given instance,combined with a clock the specific occupied opening can be identified.

With respect to FIG. 11A, a packaging assembly 100 according to anexemplary embodiment is shown. Elements not described below aresubstantially the same as those of the first embodiment.

The sensor array 240 comprises a single device sensor. The sensor array240 is a radio-frequency identification (RFID) reader comprising aradio-frequency antenna. The sensor array 240 is mounted on orimmediately behind the panel 150. The sensor array 240 generates anelectromagnetic field in front of the panel 150, and detects a responsesignal from a device tag 30 which is passed through the field.

The user presents the device tag 30 of each injection device 10 to thesensor array 240 as the injection device 10 is added to or removed fromthe packaging assembly 100. As shown, the blue led 221 is flashing toindicate that the scheduled dosing time is due. The user removes theinjection device 10 from the opening 151 and presents the device tag 30to the sensor array 240, before the medicament is administered. Afteradministration of the medicament, the reset button is pushed, as normal.In the case of adding an injection device 10 to the packaging assembly100, a flashing white LED may indicate which empty opening 151 theinjection device 10 should be inserted into.

The RFID reader of the sensor array 240 may be combined with a pluralityof light gates to indicate the occupancy of each opening 151, as shownin either of FIG. 10B or 10C.

With respect to FIG. 11B, a packaging assembly 100 according to anexemplary embodiment is shown. Elements not described below aresubstantially the same as those of the first embodiment.

The sensor array 240 comprises a single device sensor. The sensor array240 is an optical sensor, e.g. a barcode reader, comprising a lightsource and a photo-detector. The sensor array 240 is mounted on thepanel 150. The sensor array 240 is configured to detect and read anoptical label such as a barcode or quick response (QR) code.

The device tag 30 of each injection device 10 comprises a QR code. Theuser presents the device tag 30 of each injection device 10 to thesensor array 240 as the injection device 10 is added to or removed fromthe packaging assembly 100. As shown, the blue led 221 is flashing toindicate that the scheduled dosing time is due. The user removes theinjection device 10 from the opening 151 and scans the device tag 30using the sensor array 240, before the medicament is administered. Afteradministration of the medicament, the reset button is pushed, as normal.In the case of adding an injection device 10 to the packaging assembly100, a flashing white LED may indicate which empty opening 151 theinjection device 10 should be inserted into.

The RFID reader of the sensor array 240 may be combined with a pluralityof light gates to indicate the occupancy of each opening 151, as shownin either of FIG. 10B or 10C.

It will be appreciated that the above described embodiments are purelyillustrative and are not limiting on the scope of the claims. Othervariations and modifications will be apparent to persons skilled in theart upon reading the present application, and some will now bedescribed.

The case of the packaging arrangement may be a generally rectangularshape or may be any other shape suitable for containing the plurality ofinjection devices. The case may be a suitable shape and size forplacement within a household refrigerator.

The case may be formed to enclose the injection devices and may besealed, Alternatively, the case may be formed as a structure forsupporting the plurality of injection devices externally. The injectiondevices may be arranged in one or more rows, e.g. a row of six or tworows of three, or in a circular arrangement. The injection devices maybe arranged to hang below a supporting structure or to be placed on topof the supporting structure.

The case may be configured to store any number of injection devices,according to the dosage requirements of the medicament. For example, thecase may store between 5 and 15 injection devices. Case may be sized tostore enough injection devices for one quarter, or for a 6 month period.Where medicament is administered more regularly, the case may storeenough injection device s for one week.

The case may be formed of an opaque material. One or more of thecomponents of the case may be formed with at least a transparentportion. A transparent portion of the case may allow the user to see thenumber of injection devices, or to see the user interface. One or morecomponents of the case may be translucent to improve visibility of avisual reminder output.

The case may be formed of a plastics material such as polyethylene,polystyrene, polycarbonate, or it may be made of any other suitablematerial. Desired properties for the material of the case includetemperature stability, moderate impact strength, resistance to cleaningfluids, a wipe-clean finish, and rigidity.

Each part of the case may be formed in a single piece e.g. a mouldedplastic part. Alternatively, parts may be machined. The body of the casemay be formed from two parts joined or attached together, or may beformed in a single part. An internal of the case may be formed as asingle large cavity, a cavity divided into a plurality of areas forholding each injection device, or may be formed as a plurality ofcavities for individually holding each injection device.

The case may comprise any number of magnets sufficient to support theweight of the packaging arrangement and injection devices. For example,the case may include 2 larger magnets or an arrangement of 6 smallermagnets. The magnets may be any permanent magnets and may be rare earthmagnets. The magnets may be formed of neodymium or may be formed ofsamarium cobalt.

The case may further comprise one or more ventilating apertures to allowair flow into the case. Alternatively, the case may be sealed when thelid is in a closed position. The lid may further comprise a rubber sealto prevent air passing into the case between the lid and the case. Thecase may be insulated to maintain the low temperature of the injectiondevices if removed from the fridge for a short period of time.

The lid may be coupled to the case with a hinge. The mechanism forconnecting the lid to the case and for allowing the lid to open andclose may take any suitable form. Instead of the hinge mechanismdescribed above, the hinge may be a butt hinge, a living hinge or someother type. The lid may be coupled to the case with a flexible and/orelastic material. The hinge may allow some translational movement aswell as pure rotational movement, to allow better viewing of or accessto the internal part of the case when the lid is open.

The hinge may allow the removal of the lid by a user. For instance, theprotrusions of each of the second hinging parts may be pushed inwards todisengage from the respective first hinging parts and decouple the lidfrom the case. The user may be provided with one or more alternativelids which may be a different design, for example, a different colour.An alternative lid may have a larger transparent portion or may beentirely opaque.

Alternatively, the lid may slidably engage with the case. The lid maycomprise runners at the edges, each configured to engage with acorresponding groove on the case. The lid may slide out of the groovesand decouple from the case. The lid may be arranged to slide to thelimit of the grooves and pivot freely in the open position. Furtheralternatively, the lid may be separate from the case and fixedlyattached thereto with a friction fit. The lid may fit tightly within theopening at the upper end of the case, or may fit over an upper portionof the case.

The lid may comprise a latch to maintain the lid in the closed position.The latch may comprise a sliding catch arranged to slidably move betweena first position and a second position. The catch may be arranged toprotrude from an edge of the lid in the first position. The catch may beconfigured to slidably retract to not protrude in the second position.The latch may comprise a spring to urge the catch to the first position.The catch may be configured to engage with an opening in the case in thefirst position when the lid is in the closed position. The catch mayengage with the opening to maintain the lid in the closed position.

The latch may be a sprung push-catch push-release mechanism. The latchmay be configured to engage with a first push into the closed positionand maintain the lid in the closed position. The latch may be configuredto disengage with a second push and allow the lid to open. The latch maybe configured to engage when the lid is closed to hold the lid in theclosed position. The latch may further comprise a release switch todisengage the latch and allow the lid to open. The release switch may bea mechanical switch or an electric switch. The release switch may be anelectric switch coupled to a code input, which is configured todisengage the lid catch when a correct code is entered.

Although the lid open sensor is described as an electromechanicalswitch, it may instead be an optical sensor arrangement, a magneticsensor arrangement or any other suitable arrangement that is configuredto detect whether the lid is open or closed or whether the lid istransitioning from a closed position to an open position.

The packaging assembly may comprise a case without a lid. The packagingassembly may not include a lid open sensor. The speaker may instead bedeactivated by the processor arrangement according to an alert timer.The processor arrangement may be configured to operate the alert timer.The processor arrangement may activate the alert timer when the speakeris controlled to output an audio reminder alert that the scheduleddosing time is due. The processor arrangement may activate the alerttimer when the scheduled dosing time is due, conditional on the fridgedoor being open. The processor arrangement may deactivate the speakerwhen the alert timer reaches 30 seconds. Alternatively, the processorarrangement may activate the alert timer at 20 seconds and count downuntil the timer expires. The processor arrangement may be configured todeactivate the speaker when the alert timer expires. The expiry timeperiod for the alert timer may be 5 seconds to 60 seconds.

The electronics system may include a device sensor to determine whetheran injection device is positioned in one of the plurality of openings.The device sensor may determine whether an injection device ispositioned within each of the openings. The processor arrangement may beconfigured to deactivate the speaker when the device sensor indicatesthat an injection device has been removed from an opening.

The device sensor may comprise one or more device switches. The deviceswitches may be arranged respectively within the openings. Each deviceswitch may be a mechanical switch. The device switch may be a normallyopen switch which is pressed to a closed position by an injection devicewhen in position in the opening. The device switch may be a membraneswitch. The device switch may be actuated by a lever located within theopening.

Each device switch may be configured to send a signal to the processorarrangement when an injection device is located within the correspondingopening. The processor arrangement may be configured to activate ordeactivate the speaker when a signal is no longer received from a deviceswitch. The processor arrangement may be configured further to reset thecountdown to the scheduled dosing time when an injection device isremoved from the opening. Alternatively, where an injection device isreplaced in the case after the dose is administered, the processorarrangement may be configured to reset the countdown when the injectiondevice is replaced. The processor arrangement may be configured tomonitor the number of injection devices in position in the packagingassembly. The processor arrangement may control the display to show thenumber of injection devices in the packaging assembly. The processorarrangement may control the electronics system to provide a notificationoutput when the packaging assembly is empty.

The retention mechanism may be arranged at the lower end of the case.The retention mechanism may be arranged to engage with the end of eachinjection device which is passed through the opening. The retentionmechanism may comprise a further plurality of openings at the lower endof the case. The further openings may be sized so as to hold theinjection devices in position with a friction fit. Alternatively, theretention mechanism may comprise a levered pincer arrangement arrangedto grip the sides of an injection device when the injection device ispushed longitudinally into the arrangement, and to release the injectiondevice when the injection device is pulled longitudinally out of thearrangement.

The retention mechanism may comprise a release switch configured todisengage the retention mechanism. The release switch may be configuredto release one or all of the injection devices. A plurality of releaseswitches may be provided for the corresponding plurality of injectiondevices. The release switch may be a mechanical switch or lever coupledto the retention mechanism. The release switch may be further coupled toan ejection mechanism. The release switch may be an electromechanicalswitch. The release switch may be controlled by the processorarrangement. The processor arrangement may control the release switch todisengage the retention mechanism conditional on the scheduled dosingtime being due. The processor arrangement may control the release switchto disengage the retention mechanism for one injection device when thescheduled dosing time is due.

The ejection mechanism may comprise one or more springs arranged to pusha portion of the respective injection devices out of the correspondingopenings. The ejection mechanism may be biased against the retentionmechanism to push each injection device when released by the retentionmechanism. The retention mechanism may be controlled to release oneinjection device, which is pushed partially out of the opening by theejection mechanism. This arrangement may provide a visual reminder alertin the form of a portion of the injection device being pushed out of theopening.

Alternatively, the ejection mechanism may comprise a motorised actuator.For example, a roller arranged perpendicularly to the plurality ofinjection devices may be driven to push the injection devices out of theopenings. The roller may push all of the injection devices equally, withthe retention mechanism configured to hold all but one of the injectiondevices in position. Further alternatively, the actuator may comprise aprotruding part from the rear of the case which is driven laterallyacross the width of the case. The protruding part may be driven along arail, or may protrude from a belt extending along the width of the case.The protruding part is configured to engage with each injection devicein turn and push the injection device out of the opening.

The time period for a reminder may be any suitable dosing period,dependent upon the medicament which is stored in the packaging assembly.The time period set until the next scheduled dosing time may be anynumber of days and may be, for example, between 2 and 60 days. The timeperiod may be a number of weeks, for example, a period of 7 days, 14days, 21 days or 28 days. The time period may be 28 days, which is 4weeks, or the time period may be 1 month. A different time period mightbe applied upon selecting the countdown timer duration, based on thecurrent weekday or the exact date within the month or the year. Adifferent time period may be set for each injection device. The timeperiod for an injection device may be recorded on the injection deviceand may be read by the device sensor. The time period for a type ofinjection device may be stored in the non-volatile memory.

The time period may be 1 or 2 days, and the display may be configured toshow the number of hours until the scheduled dosing time is due.Similarly, for a time period on the order of a number of hours, thedisplay may show a number of minutes.

A time period may be fixed for all injection devices. A predeterminedtime period may be stored in the non-volatile memory. Alternatively, atimer duration switch may be configured to select between any two timeperiods. For example, a first switch position may correspond to a timeperiod of 7 days and a second switch position may correspond to a timeperiod of 14 days. Alternatively, the timer duration switch may be amulti-positional switch, for example, a rotary switch or a dial. Thetime period may be set in conjunction with the display, wherein a firstuser input causes the display to show the current time period, and asecond input is used to adjust the time period. A third input might beused to confirm the new settings.

Alternatively, the time period might be adjusted with a specificsequence of inputs using the reset button. For example, holding thereset button for a longer period of time, e.g. longer than 5 seconds,may initiate a “time period adjustment mode”. The display may show thecurrent timer duration, e.g. the display may show “14” to indicate 14days. In this mode, pushing the reset button again for less than 5seconds may increase the period incrementally. For example, a singlebutton push may add 1 day, and the displayed value is changedaccordingly. In this way, the user can adjust the period up to apredefined maximum value, e.g. “28”. If the user pushes another time,then the time period may be dropped to a predefined minimum value, e.g.“14”. If the user again holds the reset button for a longer period oftime, e.g. longer than 5 seconds, the currently displayed value may bestored as the new time period and the normal operation is resumed.Alternatively, the value may be stored and normal operation resumedafter a predetermined period with no input, e.g. after 10 seconds.

In some cases, the processor arrangement may not remove a redundantcountdown timer. The countdown timer for a type of injection device maybe maintained by the processor arrangement if the packaging assembly nolonger contains an injection device of the corresponding type. A certaindevice type may be removed from the packaging assembly and laterreplaced with the same countdown timer. The processor arrangement maysuppress an alert if the packaging assembly no longer contains aninjection device of the corresponding device type when the countdowntimer expires. Alternatively, the processor arrangement may output analert. The processor arrangement may output a message to indicate acertain device type which is not contained in the packaging assembly.

The door timer and reset timer may operate on any suitable timeframe.For example, the user interface may enter the partial sleep mode if thefridge door is open for 10 minutes or 15 minutes. The reset button maybe configured to reset the countdown timer if pressed for 1 second or upto 5 seconds.

The display may comprise more than 2 LED arrays, to accommodate largernumbers and messages, or more be a single LED array only. Alternatively,the display may comprise any form of electronic display suitable fordisplaying a number and/or a message, for example, the display may be anarray of LED pixels, an LCD or e-paper screen, or a split-flap display.The display may be a display which is capable of displaying pseudo-3Dimages or video, e.g. a lenticular display. The display may be arrangedin a peripheral module which is separate from the case. The displaymodule may be connected to electrics system with a wired or wirelessconnection. The electronics system may comprise any display driver whichis suitable for chosen display.

The display may be configured to provide further status information, ormore detail, in the form of text messages on the display. For example,the display may provide a visual reminder that the scheduled dosing timeis due by showing a reminder message in addition to, or instead of,flashing the number 00. The output of the number 00 is an example of areminder message. The display may be controlled to show the number ofinjection devices remaining in the packaging assembly. The processorarrangement may be configured to determine the number of injectiondevices according to an input from the sensor array. Alternatively, theprocessor arrangement may be configured to monitor the number of timesthat a scheduled dosing time has passed. The display may be controlledto show a notification message when the packaging assembly is empty.

The display might be used to display a short sequence of pictures or avideo, in 2D or in 3D, to show the correct usage or application of theinjection device. The display may show any other useful information oradvice connected to the therapy or the daily life of the patient.

The display may be controlled to display a warm-up time period when aninjection device is removed from the packaging assembly. The display maybe controlled in conjunction with the sensor array. When the scheduleddosing time for an injection device is due, the sensor array may beoperated to detect the removal of the injection device. The display maydisplay the warm-up time period when the sensor array detects theremoval of the injection device. The warm-up time period represents therecommend time required for the injection device to reach roomtemperature. The processor arrangement may perform a timing operationbased on the warm-up time period.

The processor arrangement may be configured to deactivate the display ofthe user interface if the lid of the case is closed. The processorarrangement may activate the LED array based on the fridge open sensor,to indicate to the user that the status of the packaging assembly isnormal, when the number of days remaining is greater than one, whetherthe lid is closed or not. The user may open the lid to activate thedisplay and show the number of days if required. When the scheduleddosing time is due, the processor arrangement may activate both the LEDarray and the display to flash, to provide a visual reminder, whetherthe lid is open or not.

The LED array may include a plurality of LEDs for each of the pluralityof openings or one LED per opening. For example, the LED array mayinclude four, five or six LEDs per opening, in order to provide agreater variety of status information. Alternatively, two or three ofthe LEDs for each opening may be replaced by a single two-colour orthree-colour LED. Alternatively, any other form of notification light orvisual output transducer may be used in place of the LED. Alternatively,the processor arrangement may flash or blink one of the plurality ofLEDs, while the remaining LEDs are off or illuminated continuously. Adifferent LED may be controlled to blink each time, to guide the user tothe next injection device for use. One LED may be flashed in a differentcolour. The processor arrangement may control a number of LEDs accordingto the number of injection devices remaining in the packaging assembly.

The speaker may be any suitable form of audio output transducer, forexample, an electro-acoustic transducer, a piezoelectric buzzer, amoving diaphragm speaker, or a mechanical bell. A vibrating alert may beused instead of or in addition to the audio output transducer. Thespeaker may output a different alert output, according to the type ofdevice. For example, the speaker may vary the periodicity of anintermittent tone, or the frequency of the tone, or may output apre-defined tone sequence e.g. a 3-tone sequence. Alternatively, thespeaker may be configured to reproduce a digital audio file stored inthe non-volatile memory. The reproduced digital audio file may be up to6 seconds long or, alternatively, may be longer than 6 seconds.

A unique or individual alert may be used for each device type or, forexample, to distinguish between alerts for different users of thepackaging assembly. Audio alerts may be customisable by the user. Inaddition to an audio alert, the audio output of the speaker may be usedto improve usability in other ways. For example, an audio output mayindicate when an injection device is detected by the sensor array. Adifferent audio output may be used according to whether the injectiondevice is being inserted or removed.

The fridge open sensor may comprise a phototransistor or, alternatively,a photoresistor or photodiode. Alternatively, the fridge open sensor maycomprise a mechanical switch. The fridge open sensor may be locatedexternally from the case and may be positioned at a hinge or frame ofthe fridge door. The fridge open sensor may be a mechanical switch whichis arranged to be pressed by the fridge door in a closed position.

The sensor array may be mounted on the panel, on a single PCB with thecomponents of the electronics system. Alternatively, the sensor arraymay be mounted on a separate PCB. The sensor array may be positioned atthe rear of the case, or internally on the upper or lower wall. Aplurality of device sensors may be provided for each of the injectiondevices. The sensor array may alternatively comprise only a singledevice sensor. A single device sensor may activate and detect aplurality of device tags. The device sensor may determine the locationof each device tag. Alternatively, a single device sensor may beexternally positioned on the case, and the user may present eachinjection device to the device sensor before placing the injectiondevice into the case. The device tag may be located at any point alongthe length of the injection device, or at either end thereof. The devicetag may be located at the proximal end of the injection device, toincrease a separation from the sensor array when the injection device islocated in the opening. Alternatively, the device tag may be located atthe distal end of the injection device, such that the sensor array canscan the device tag when the injection device is located in the opening.

Alternative device sensors may include optical sensors. Optical devicetags such as, for example, barcodes or QR codes, may be provided on theplurality of injection devices. Alternatively, optical sensors maydetermine a colour or visual marking on an injection device to determinethe type of injection device. In some embodiments, an optical sensordetects the presence of an injection device without receiving furtherdevice information. A device sensor may be implemented with a mechanicalswitch arranged to be pressed by an injection device when placed in theopening. The processor arrangement may determine the number of injectiondevices, the location of the injection devices and generate a deviceindex for each injection device based on the detected presence of theinjection devices. An alternative processor arrangement may iterate thedevice index only if both the device type and expiry date of aninjection device match those of another injection device.

Alternative countdown timer implementations include off-chip and on-chipstate-based logic circuits with clock devices, and other forms will beapparent to the skilled person.

The PCB and components of the electronics system may be sealed forprotection. For example, the PCB may be coated on each side with a waterresistant lacquer or another suitable coating. The electronics systemmay be coated for protection from moisture or humidity in the interiorof a household fridge.

The packaging assembly may include a greater or smaller number ofbatteries, according to the power requirements of the electronicssystem. For example, the packaging assembly may include a single batterypower pack. The battery or batteries may be removable and replaceable,or may be fixed within the case of the packaging assembly.Alternatively, the packaging assembly may be adapted for a mains powersupply, or any alternative power supply.

The term “device type” is used to describe the physical sum of a drugcontainer with a given drug and a given drug concentration, and themechanical/electronical object performing relevant steps of the druginjection into the patient. The device type may be represented by onefield in the device table or alternatively, for example, by two or moredependent fields to define the device type e.g. by specifying any of themedicament, concentration and delivery method of the injection device.

The terms “drug” or “medicament” are used synonymously herein anddescribe a pharmaceutical formulation containing one or more activepharmaceutical ingredients or pharmaceutically acceptable salts orsolvates thereof, and optionally a pharmaceutically acceptable carrier.An active pharmaceutical ingredient (“API”), in the broadest terms, is achemical structure that has a biological effect on humans or animals. Inpharmacology, a drug or medicament is used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being. A drug or medicament may be used for alimited duration, or on a regular basis for chronic disorders.

As described below, a drug or medicament can include at least one API,or combinations thereof, in various types of formulations, for thetreatment of one or more diseases. Examples of API may include smallmolecules having a molecular weight of 500 Da or less; polypeptides,peptides and proteins (e.g., hormones, growth factors, antibodies,antibody fragments, and enzymes); carbohydrates and polysaccharides; andnucleic acids, double or single stranded DNA (including naked and cDNA),RNA, antisense nucleic acids such as antisense DNA and RNA, smallinterfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleicacids may be incorporated into molecular delivery systems such asvectors, plasmids, or liposomes. Mixtures of one or more drugs are alsocontemplated.

The term “drug delivery device” shall encompass any type of device orsystem configured to dispense a drug or medicament into a human oranimal body. Without limitation, a drug delivery device may be aninjection device (e.g., syringe, pen injector, auto injector,large-volume device, pump, perfusion system, or other device configuredfor intraocular, subcutaneous, intramuscular, or intravasculardelivery), skin patch (e.g., osmotic, chemical, micro-needle), inhaler(e.g., nasal or pulmonary). The presently described drugs may beparticularly useful with injection devices that include a needle, e.g.,a hypodermic needle for example having a Gauge number of 24 or higher.

The drug or medicament may be contained in a primary package or “drugcontainer” adapted for use with a drug delivery device. The drugcontainer may be, e.g., a cartridge, syringe, reservoir, or other solidor flexible vessel configured to provide a suitable chamber for storage(e.g., short- or long-term storage) of one or more drugs. For example,in some instances, the chamber may be designed to store a drug for atleast one day (e.g., 1 to at least 30 days). In some instances, thechamber may be designed to store a drug for about 1 month to about 2years. Storage may occur at room temperature (e.g., about 20° C.), orrefrigerated temperatures (e.g., from about −4° C. to about 4° C.). Insome instances, the drug container may be or may include a dual-chambercartridge configured to store two or more components of thepharmaceutical formulation to-be-administered (e.g., an API and adiluent, or two different drugs) separately, one in each chamber. Insuch instances, the two chambers of the dual-chamber cartridge may beconfigured to allow mixing between the two or more components prior toand/or during dispensing into the human or animal body. For example, thetwo chambers may be configured such that they are in fluid communicationwith each other (e.g., by way of a conduit between the two chambers) andallow mixing of the two components when desired by a user prior todispensing. Alternatively or in addition, the two chambers may beconfigured to allow mixing as the components are being dispensed intothe human or animal body.

The drugs or medicaments contained in the drug delivery devices asdescribed herein can be used for the treatment and/or prophylaxis ofmany different types of medical disorders. Examples of disordersinclude, e.g., diabetes mellitus or complications associated withdiabetes mellitus such as diabetic retinopathy, thromboembolismdisorders such as deep vein or pulmonary thromboembolism. Furtherexamples of disorders are acute coronary syndrome (ACS), angina,myocardial infarction, cancer, macular degeneration, inflammation, hayfever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs anddrugs are those as described in handbooks such as Rote Liste 2014, forexample, without limitation, main groups 12 (anti-diabetic drugs) or 86(oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type 1 or type2 diabetes mellitus or complications associated with type 1 or type 2diabetes mellitus include an insulin, e.g., human insulin, or a humaninsulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1analogues or GLP-1 receptor agonists, or an analogue or derivativethereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or apharmaceutically acceptable salt or solvate thereof, or any mixturethereof. As used herein, the terms “analogue” and “derivative” refers toany substance which is sufficiently structurally similar to the originalsubstance so as to have substantially similar functionality or activity(e.g., therapeutic effectiveness). In particular, the term “analogue”refers to a polypeptide which has a molecular structure which formallycan be derived from the structure of a naturally occurring peptide, forexample that of human insulin, by deleting and/or exchanging at leastone amino acid residue occurring in the naturally occurring peptideand/or by adding at least one amino acid residue. The added and/orexchanged amino acid residue can either be codable amino acid residuesor other naturally occurring residues or purely synthetic amino acidresidues. Insulin analogues are also referred to as “insulin receptorligands”. In particular, the term “derivative” refers to a polypeptidewhich has a molecular structure which formally can be derived from thestructure of a naturally occurring peptide, for example that of humaninsulin, in which one or more organic substituent (e.g. a fatty acid) isbound to one or more of the amino acids. Optionally, one or more aminoacids occurring in the naturally occurring peptide may have been deletedand/or replaced by other amino acids, including non-codeable aminoacids, or amino acids, including non-codeable, have been added to thenaturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) humaninsulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulinglulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28)human insulin (insulin aspart); human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Examples of insulin derivatives are, for example,B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®);B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin;B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 humaninsulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) humaninsulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30)human insulin (insulin degludec, Tresiba®);B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyhepta-¬decanoyl) human insulin.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, forexample, Lixisenatide (Lyxumia®, Exenatide (Exendin-4, Byetta®,Bydureon®, a 39 amino acid peptide which is produced by the salivaryglands of the Gila monster), Liraglutide (Victoza®), Semaglutide,Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®),rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3,GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen,Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701,MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864,ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium(Kynamro®), a cholesterol-reducing antisense therapeutic for thetreatment of familial hypercholesterolemia.

Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin,Saxagliptin, Berberine. Examples of hormones include hypophysis hormonesor hypothalamus hormones or regulatory active peptides and theirantagonists, such as Gonadotropine (Follitropin, Lutropin,Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronicacid, a heparin, a low molecular weight heparin or an ultra-lowmolecular weight heparin or a derivative thereof, or a sulphatedpolysaccharide, e.g. a poly-sulphated form of the above-mentionedpolysaccharides, and/or a pharmaceutically acceptable salt thereof. Anexample of a pharmaceutically acceptable salt of a poly-sulphated lowmolecular weight heparin is enoxaparin sodium. An example of ahyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodiumhyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulinmolecule or an antigen-binding portion thereof. Examples ofantigen-binding portions of immunoglobulin molecules include F(ab) andF(ab′)2 fragments, which retain the ability to bind antigen. Theantibody can be polyclonal, monoclonal, recombinant, chimeric,de-immunized or humanized, fully human, non-human, (e.g., murine), orsingle chain antibody. In some embodiments, the antibody has effectorfunction and can fix complement. In some embodiments, the antibody hasreduced or no ability to bind an Fc receptor. For example, the antibodycan be an isotype or subtype, an antibody fragment or mutant, which doesnot support binding to an Fc receptor, e.g., it has a mutagenized ordeleted Fc receptor binding region. The term antibody also includes anantigen-binding molecule based on tetravalent bispecific tandemimmunoglobulins (TBTI) and/or a dual variable region antibody-likebinding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptidederived from an antibody polypeptide molecule (e.g., an antibody heavyand/or light chain polypeptide) that does not comprise a full-lengthantibody polypeptide, but that still comprises at least a portion of afull-length antibody polypeptide that is capable of binding to anantigen. Antibody fragments can comprise a cleaved portion of a fulllength antibody polypeptide, although the term is not limited to suchcleaved fragments. Antibody fragments that are useful in the presentdisclosureinclude, for example, Fab fragments, F(ab′)2 fragments, scFv(single-chain Fv) fragments, linear antibodies, monospecific ormultispecific antibody fragments such as bispecific, trispecific,tetraspecific and multispecific antibodies (e.g., diabodies, triabodies,tetrabodies), monovalent or multivalent antibody fragments such asbivalent, trivalent, tetravalent and multivalent antibodies, minibodies,chelating recombinant antibodies, tribodies or bibodies, intrabodies,nanobodies, small modular immunopharmaceuticals (SMIP), binding-domainimmunoglobulin fusion proteins, camelized antibodies, and VHH containingantibodies. Additional examples of antigen-binding antibody fragmentsare known in the art.

The terms “Complementarity-determining region” or “CDR” refer to shortpolypeptide sequences within the variable region of both heavy and lightchain polypeptides that are primarily responsible for mediating specificantigen recognition. The term “framework region” refers to amino acidsequences within the variable region of both heavy and light chainpolypeptides that are not CDR sequences, and are primarily responsiblefor maintaining correct positioning of the CDR sequences to permitantigen binding. Although the framework regions themselves typically donot directly participate in antigen binding, as is known in the art,certain residues within the framework regions of certain antibodies candirectly participate in antigen binding or can affect the ability of oneor more amino acids in CDRs to interact with antigen. Examples ofantibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g.,Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

Pharmaceutically acceptable salts of any API described herein are alsocontemplated for use in a drug or medicament in a drug delivery device.Pharmaceutically acceptable salts are for example acid addition saltsand basic salts.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the APIs, formulations,apparatuses, methods, systems and embodiments described herein may bemade without departing from the full scope and spirit of the presentdisclosure, which encompass such modifications and any and allequivalents thereof.

1. A packaging assembly comprising: a case configured to at leastpartially contain a plurality of injection devices for delivering amedicament; a processor arrangement configured to initiate a countdowntimer based on a dosing period for at least one injection device of theplurality of injection devices; and an input device configured to resetthe countdown timer upon being pressed by a user, wherein the processorarrangement is further configured to: initiate a reset timer configuredto monitor a period of time that the input device has been pressed, andinitiate a “time period adjustment mode” when the reset timer determinesthat the period of time that the input device has been pressed exceeds athreshold time period.
 2. The packaging assembly of claim 1, wherein thethreshold time period is 5 seconds.
 3. The packaging assembly of claim1, wherein in the “time period adjustment mode,” the processor isconfigured to increase a timer duration incrementally upon the inputdevice being pressed again for less than the threshold time period. 4.The packaging assembly of claim 1, wherein the period of time is a firstperiod of time, and wherein in the “time period adjustment mode,” theprocessor is configured to save a timer duration upon the input devicebeing pressed again for a second period of time that exceeds thethreshold time period.
 5. The packaging assembly of claim 1, wherein theperiod of time is a first period of time, and wherein the processorarrangement is configured to reset the countdown timer when the inputdevice is pressed for a second period of time that does not exceed thethreshold time period.
 6. The packaging assembly of claim 1, furthercomprising at least one device sensor that is configured to output asignal when one or more injection devices of the plurality of injectiondevices are located in the packaging assembly.
 7. The packaging assemblyof claim 6, wherein the at least one device sensor is configured todetect injection information relating to the one or more injectiondevices that have been detected.
 8. The packaging assembly of claim 6,further comprising an injection information storage configured toretrieve injection information relating to the one or more injectiondevices that have been detected based on one or more respective detectedidentities.
 9. The packaging system of claim 8, wherein the injectioninformation comprises at least one of a dosing time period, a roomtemperature time period, or an expiry date.
 10. The packaging assemblyof claim 1, wherein the input device comprises a reset button.
 11. Thepackaging assembly of claim 1, further comprising the at least oneinjection device of the plurality of injection devices received withinthe case, wherein the at least one injection device comprises amedicament.
 12. A method of operating a packaging assembly, the methodcomprising: initiating, by a processor arrangement, a reset timer tomonitor a period of time that an input device of the packaging assemblyhas been pressed; and initiating, by the processor arrangement, a “timeperiod adjustment mode” when the reset timer determines that the periodof time that the input device has been pressed exceeds a threshold timeperiod.
 13. The method of claim 12, wherein the packaging assemblyfurther comprises a case configured to at least partially contain aplurality of injection devices for delivering a medicament.
 14. Themethod of claim 13, wherein the processor arrangement is configured toinitiate a countdown timer based on a dosing period for at least oneinjection device of the plurality of injection devices.
 15. The methodof claim 14, wherein the input device is configured to reset thecountdown timer upon being pressed by a user.
 16. The method of claim12, further comprising displaying a current timer duration at a display.17. The method of claim 16, further comprising: initiating, by theprocessor arrangement, a second reset timer to monitor the period oftime that the input device has been pressed; and increasing the currenttimer duration incrementally when the second reset timer determines thatthe period of time that the input device has been pressed does notexceed the threshold time period.
 18. The method of claim 17, wherein anincremental increase of the current timer duration comprises one day.19. The method of claim 17, further comprising: initiating, by theprocessor arrangement, a third reset timer to monitor the period of timethat the input device has been pressed; saving, by the processorarrangement, the current timer duration; and exiting, by the processorarrangement, the “time period adjustment mode” when the third resettimer determines that the period of time that the input device has beenpressed exceeds the threshold time period.
 20. The method of claim 13,wherein the packaging assembly further comprises the at least oneinjection device of the plurality of injection devices received withinthe case, and wherein the at least one injection device comprises amedicament.